ropinirole Oral Tablet

Brand(s)
Requip
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-08-29)
Oldest Current Product
1997-10-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ROPINIROLE
FDAOB
ORAL\TABLET\ROPINIROLE HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\ROPINIROLE HYDROCHLORIDE
ORAL\TABLET, FILM COATED\ROPINIROLE HYDROCHLORIDE
ORAL\TABLET\ROPINIROLE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\ROPINIROLE
ORAL\TABLET, FILM COATED\ROPINIROLE
ORAL\TABLET\ROPINIROLE

product(s) by strength(s)

ropinirole 0.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074890RequipNDAGlaxosmithkline Llc1997-10-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540116ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785525ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009045994ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4009046373ANDAMajor2014-10-01ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429e7ef58c0-73ba-4af2-b82b-a33954ec44df
5231550121ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
6435470268ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
7467080030ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
8556480154ANDAWockhardt Limited2008-05-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079050414cd6c4-4926-4dfc-93c4-f04f4b7eeac3
9605052865ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
10642200420ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
11646790154ANDAWockhardt Usa Llc.2008-05-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790500fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0
12658410712ANDACadila Healthcare Limited2009-09-23ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904115525c364-3574-4029-89dc-1efc6d85c03c
13683820338ANDAZydus Pharmaceuticals (Usa) Inc.2009-09-23ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090411c3b91380-1a23-4b44-bd1d-4888e43fe8b9
14684620253ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950792ANDARebel Distributors Corp2008-05-21ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200201ANDA0782301cb783ed-5496-4b4d-995b-e81157f9f8d1
2548685952ANDAPhysicians Total Care, Inc.2008-10-22ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200201ANDA0782301c1b2587-3d65-4d21-b913-9a3918435b8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157536ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-27ROPINIROLE HYDROCHLORIDEORALTABLET003785525ANDA078881bee2269a-22e8-413f-99bb-ea64169b4491
2433530920ANDAAphena Pharma Solutions - Tennessee, Llc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLET000540116ANDA0778524c88de4d-64b8-43e1-9dbe-c38eede024a8
3532170166ANDAAidarex Pharmaceuticals Llc2009-09-18ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550121ANDA090429b11ca8cb-289c-4015-84b3-be905de46aff
4636294977ANDABryant Ranch Prepack2009-09-18ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550121ANDA090429b8fbd5b8-8797-4b95-b9a6-40a28a76805d
5680840195ANDAAmerican Health Packaging2014-01-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550121ANDA090429b9ff238b-1e7c-4663-aa70-81425d0ced9e
6680840305ANDAAmerican Health Packaging2013-07-05ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED646790154ANDA079050f1b2850e-097b-4a59-9c65-7cde77f30894
7681514071ANDACarilion Materials Management2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLET000540116ANDA077852417964dc-94c1-475e-b954-9d3e6fcba0e0
8682587162ANDADispensing Solutions, Inc.2009-09-18ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550121ANDA090429c1c74e92-c34f-4ab7-b541-5ac0b738c846

ropinirole 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074891RequipNDAGlaxosmithkline Llc1997-10-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540117ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785550ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009045995ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4231550122ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
5435470269ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
6467080031ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
7605052866ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
8642200421ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
9684620254ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685953ANDAPhysicians Total Care, Inc.2008-10-22ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200202ANDA0782301c1b2587-3d65-4d21-b913-9a3918435b8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157537ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-27ROPINIROLE HYDROCHLORIDEORALTABLET003785550ANDA078881bee2269a-22e8-413f-99bb-ea64169b4491
2216950793ANDARebel Distributors Corp2009-09-18ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550122ANDA09042988c5b939-a658-4972-b849-e5c00a447b53
3636294798ANDABryant Ranch Prepack2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED435470269ANDA0781108e23aac9-446c-43b5-89ab-fc596b766df0
4680840201ANDAAmerican Health Packaging2014-01-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550122ANDA090429b9ff238b-1e7c-4663-aa70-81425d0ced9e
5680840306ANDAAmerican Health Packaging2013-07-05ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED646790155ANDA079050f1b2850e-097b-4a59-9c65-7cde77f30894
6681514072ANDACarilion Materials Management2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLET000540117ANDA077852366a173b-d6a0-4c96-8539-dad363159d98

ropinirole 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074892RequipNDAGlaxosmithkline Llc1997-10-01ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540118ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785501ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009045996ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4009046374ANDAMajor2014-10-01ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429e7ef58c0-73ba-4af2-b82b-a33954ec44df
5231550123ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
6435470270ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
7467080032ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
8605052867ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
9642200422ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
10684620255ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950794ANDARebel Distributors Corp2008-05-21ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200203ANDA0782301cb783ed-5496-4b4d-995b-e81157f9f8d1
2548685897ANDAPhysicians Total Care, Inc.2008-05-21ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200203ANDA0782301c1b2587-3d65-4d21-b913-9a3918435b8e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157538ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-27ROPINIROLE HYDROCHLORIDEORALTABLET003785501ANDA078881bee2269a-22e8-413f-99bb-ea64169b4491
2165900643ANDAStat Rx Usa Llc2009-09-17ROPINIROLE HYDROCHLORIDEORALTABLET003785501ANDA078881a543b4fb-186a-40f4-8c88-861b7db2b3e9
3353560623ANDALake Erie Medical Dba Quality Care Products Llc2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED684620255ANDA09013517ddb8cf-7373-487f-aab9-afdf440c8d6e
4433530912ANDAAphena Pharma Solutions - Tennessee, Llc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLET000540118ANDA0778524c88de4d-64b8-43e1-9dbe-c38eede024a8
5551547130ANDACardinal Health2014-01-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED680840311ANDA090429f37d8d11-ea44-4e45-a239-43f76316197e
6552890470RequipNDAPd-Rx Pharmaceuticals, Inc.1997-10-01ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED000074892NDA0206583683d5bf-0159-4a81-ba37-f5ef448afdd7
7636293760RequipNDABryant Ranch Prepack1997-10-01ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED000074892NDA0206585f704e82-0c0f-4df9-b221-f8982b318ee2
8636293807ANDABryant Ranch Prepack2009-09-18ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550123ANDA090429d52d231b-f407-f6a0-466e-0f714244010d
9680840307ANDAAmerican Health Packaging2013-07-05ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED646790171ANDA079050f1b2850e-097b-4a59-9c65-7cde77f30894
10680840311ANDAAmerican Health Packaging2014-01-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550123ANDA090429b9ff238b-1e7c-4663-aa70-81425d0ced9e
11681514073ANDACarilion Materials Management2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLET000540118ANDA0778521cdb9d61-5bbc-4026-a449-fec8c9ce5c65

ropinirole 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074893RequipNDAGlaxosmithkline Llc1997-10-03ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540119ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785502ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009045997ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4231550124ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
5435470271ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
6467080033ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
7605052868ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
8642200423ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
9684620256ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685912ANDAPhysicians Total Care, Inc.2008-06-27ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200204ANDA0782301c1b2587-3d65-4d21-b913-9a3918435b8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157539ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-27ROPINIROLE HYDROCHLORIDEORALTABLET003785502ANDA078881bee2269a-22e8-413f-99bb-ea64169b4491
2165900734ANDAStat Rx Usa Llc2009-09-17ROPINIROLE HYDROCHLORIDEORALTABLET003785502ANDA078881a543b4fb-186a-40f4-8c88-861b7db2b3e9
3433530911ANDAAphena Pharma Solutions - Tennessee, Llc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLET000540119ANDA0778524c88de4d-64b8-43e1-9dbe-c38eede024a8
4636294971ANDABryant Ranch Prepack2009-09-18ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550124ANDA0904293d4ea23a-c4d9-4983-94e7-b76ed752a641
5680840308ANDAAmerican Health Packaging2013-07-05ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED646790172ANDA079050f1b2850e-097b-4a59-9c65-7cde77f30894
6680840332ANDAAmerican Health Packaging2014-01-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED231550124ANDA090429b9ff238b-1e7c-4663-aa70-81425d0ced9e
7682587163ANDADispensing Solutions, Inc.2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED684620256ANDA090135caa8f322-325d-4117-a564-c87391ebf6fe

ropinirole 3 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074895RequipNDAGlaxosmithkline Llc2001-06-19ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540120ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785503ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009045998ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4231550125ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
5435470272ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
6467080034ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
7605052869ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
8642200424ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
9684620257ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157567ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-10-27ROPINIROLE HYDROCHLORIDEORALTABLET003785503ANDA078881bee2269a-22e8-413f-99bb-ea64169b4491

ropinirole 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074896RequipNDAGlaxosmithkline Llc1999-09-21ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540121ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785504ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009045999ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4231550126ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
5435470273ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
6467080035ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
7605052870ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
8642200425ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
9684620258ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685914ANDAPhysicians Total Care, Inc.2008-07-02ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200206ANDA0782301c1b2587-3d65-4d21-b913-9a3918435b8e

ropinirole 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074894RequipNDAGlaxosmithkline Llc1997-10-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020658de0bb94f-4fd8-4f27-5ba6-6f392dd5160f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540122ANDARoxane Laboratories, Inc2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA077852e05b026c-c46f-473a-b23c-56b463f95df1
2003785505ANDAMylan Pharmaceuticals Inc.2008-05-05ROPINIROLE HYDROCHLORIDEORALTABLETANDA078881f5ce07b9-ad0d-4b72-9daf-8662775af093
3009046000ANDAMajor2009-07-08ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0790509a8eb66e-21fe-468d-aeec-44a8aa4c7869
4231550127ANDAHeritage Pharmaceuticals Inc.2014-09-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090429cd4d1aeb-debf-458a-83c1-fa098d4d3415
5435470274ANDASolco Healthcare U.S., Llc2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781107734ef0b-584f-42dd-a8b5-adbdf4e4df93
6467080036ANDAAlembic Limited2013-09-12ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0904299a25f575-09ab-4d32-b73e-5426f08c00c4
7605052871ANDAApotex Corp2013-03-29ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA079165bccd27a8-a65e-951c-1bbf-31f4dfe8a946
8642200426ANDAZhejiang Huahai Pharmaceutical Co., Ltd.2011-08-10ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0781106f7fc849-8a38-47a1-bc39-54801a86416c
9684620259ANDAGlenmark Generics Inc., Usa2010-02-25ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09013585971b31-6f7d-421c-bf3c-5b33f3c1e781

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950798ANDARebel Distributors Corp2008-05-21ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200207ANDA0782301cb783ed-5496-4b4d-995b-e81157f9f8d1
2548686167ANDAPhysicians Total Care, Inc.2010-09-08ROPINIROLE HYDROCHLORIDEORALTABLET, COATED647200207ANDA0782301c1b2587-3d65-4d21-b913-9a3918435b8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1636294641ANDABryant Ranch Prepack2011-09-20ROPINIROLE HYDROCHLORIDEORALTABLET, FILM COATED435470274ANDA078110ed314bc0-7ceb-441c-bf18-d24df66fbc5f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077460ROPINIROLE HYDROCHLORIDEG AND W LABORATORIES INC2008-05-05ANDA077460_001, ANDA077460_002, ANDA077460_003, ANDA077460_004, ANDA077460_005, ANDA077460_006, ANDA077460_007
2ANDA077852ROPINIROLE HYDROCHLORIDEROXANE LABORATORIES INC2008-05-05ANDA077852_001, ANDA077852_002, ANDA077852_003, ANDA077852_004, ANDA077852_005, ANDA077852_006, ANDA077852_007
3ANDA078110ROPINIROLE HYDROCHLORIDEPRINSTON PHARMACEUTICAL INC2008-05-05ANDA078110_001, ANDA078110_002, ANDA078110_003, ANDA078110_004, ANDA078110_005, ANDA078110_006, ANDA078110_007
4ANDA078230ROPINIROLE HYDROCHLORIDETrueCOREPHARMA LLC2008-05-20ANDA078230_001, ANDA078230_002, ANDA078230_003, ANDA078230_004, ANDA078230_005, ANDA078230_006, ANDA078230_007
5ANDA078881ROPINIROLE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2008-05-05ANDA078881_001, ANDA078881_002, ANDA078881_003, ANDA078881_004, ANDA078881_005, ANDA078881_006, ANDA078881_007
6ANDA079050ROPINIROLE HYDROCHLORIDEWOCKHARDT LTD2008-05-29ANDA079050_001, ANDA079050_002, ANDA079050_003, ANDA079050_004, ANDA079050_005, ANDA079050_006, ANDA079050_007
7ANDA079165ROPINIROLE HYDROCHLORIDEAPOTEX INC2012-02-07ANDA079165_001, ANDA079165_002, ANDA079165_003, ANDA079165_004, ANDA079165_005, ANDA079165_006, ANDA079165_007
8ANDA079229ROPINIROLE HYDROCHLORIDEORCHID HEALTHCARE2012-11-28ANDA079229_001, ANDA079229_002, ANDA079229_003, ANDA079229_004, ANDA079229_005, ANDA079229_006, ANDA079229_007
9ANDA090135ROPINIROLE HYDROCHLORIDEGLENMARK GENERICS LTD2010-02-25ANDA090135_001, ANDA090135_002, ANDA090135_003, ANDA090135_004, ANDA090135_005, ANDA090135_006, ANDA090135_007
10ANDA090411ROPINIROLE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2009-06-01ANDA090411_001, ANDA090411_002, ANDA090411_003, ANDA090411_004, ANDA090411_005, ANDA090411_006, ANDA090411_007
11ANDA090429ROPINIROLE HYDROCHLORIDEALEMBIC LTD2010-03-24ANDA090429_001, ANDA090429_002, ANDA090429_003, ANDA090429_004, ANDA090429_005, ANDA090429_006, ANDA090429_007
12NDA020658REQUIPGLAXOSMITHKLINE LLC1997-09-19NDA020658_001, NDA020658_002, NDA020658_003, NDA020658_004, NDA020658_005, NDA020658_006, NDA020658_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077460_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
2ANDA077460_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
3ANDA077460_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
4ANDA077460_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
5ANDA077460_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
6ANDA077460_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
7ANDA077460_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2008-05-19ROPINIROLE HYDROCHLORIDE
8ANDA077852_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
9ANDA077852_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
10ANDA077852_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
11ANDA077852_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
12ANDA077852_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
13ANDA077852_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
14ANDA077852_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2008-05-19ROPINIROLE HYDROCHLORIDE
15ANDA078110_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
16ANDA078110_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
17ANDA078110_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
18ANDA078110_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
19ANDA078110_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
20ANDA078110_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
21ANDA078110_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2008-07-11ROPINIROLE HYDROCHLORIDE
22ANDA078230_001discontinuedROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
23ANDA078230_002discontinuedROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
24ANDA078230_003discontinuedROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
25ANDA078230_004discontinuedROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
26ANDA078230_005discontinuedROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
27ANDA078230_006discontinuedROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
28ANDA078230_007discontinuedROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalse2008-05-20ROPINIROLE HYDROCHLORIDE
29ANDA078881_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
30ANDA078881_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
31ANDA078881_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
32ANDA078881_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
33ANDA078881_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
34ANDA078881_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2008-05-05ROPINIROLE HYDROCHLORIDE
35ANDA078881_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2008-05-19ROPINIROLE HYDROCHLORIDE
36ANDA079050_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
37ANDA079050_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
38ANDA079050_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
39ANDA079050_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
40ANDA079050_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
41ANDA079050_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
42ANDA079050_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2008-05-29ROPINIROLE HYDROCHLORIDE
43ANDA079165_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
44ANDA079165_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
45ANDA079165_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
46ANDA079165_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
47ANDA079165_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
48ANDA079165_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
49ANDA079165_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2012-02-07ROPINIROLE HYDROCHLORIDE
50ANDA079229_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
51ANDA079229_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
52ANDA079229_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
53ANDA079229_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
54ANDA079229_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
55ANDA079229_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
56ANDA079229_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2012-11-28ROPINIROLE HYDROCHLORIDE
57ANDA090135_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
58ANDA090135_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
59ANDA090135_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
60ANDA090135_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
61ANDA090135_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
62ANDA090135_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
63ANDA090135_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2010-02-25ROPINIROLE HYDROCHLORIDE
64ANDA090411_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
65ANDA090411_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
66ANDA090411_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
67ANDA090411_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
68ANDA090411_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
69ANDA090411_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
70ANDA090411_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2009-06-01ROPINIROLE HYDROCHLORIDE
71ANDA090429_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
72ANDA090429_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
73ANDA090429_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
74ANDA090429_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
75ANDA090429_005RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
76ANDA090429_006RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
77ANDA090429_007RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB2010-03-24ROPINIROLE HYDROCHLORIDE
78NDA020658_001RXROPINIROLE HYDROCHLORIDE (EQ 0.25MG BASE)ORALTABLETTrueAB1997-09-19REQUIP
79NDA020658_002RXROPINIROLE HYDROCHLORIDE (EQ 0.5MG BASE)ORALTABLETFalseAB1997-09-19REQUIP
80NDA020658_003RXROPINIROLE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1997-09-19REQUIP
81NDA020658_004RXROPINIROLE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB1997-09-19REQUIP
82NDA020658_005RXROPINIROLE HYDROCHLORIDE (EQ 5MG BASE)ORALTABLETFalseAB1997-09-19REQUIP
83NDA020658_006RXROPINIROLE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB1999-01-27REQUIP
84NDA020658_007RXROPINIROLE HYDROCHLORIDE (EQ 4MG BASE)ORALTABLETFalseAB1999-01-27REQUIP

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 (view SPL)Ropinirole Tablets, USPprescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-03-052646790154
217ddb8cf-7373-487f-aab9-afdf440c8d6e (view SPL)rOPINIRole Tablets USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-08-291353560623
31c1b2587-3d65-4d21-b913-9a3918435b8e (view SPL)Ropinirole Hydrochloride Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-11-257548685897, 548685912, 548685914, 548685952, 548685953, 548686167
41cb783ed-5496-4b4d-995b-e81157f9f8d1 (view SPL)Ropinirole Hydrochloride Tablets 0.25 mg, 1 mg and 5 mg Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-111216950792, 216950794, 216950798
51cdb9d61-5bbc-4026-a449-fec8c9ce5c65 (view SPL)rOPINIRole Tablets USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-02-252681514073
6366a173b-d6a0-4c96-8539-dad363159d98 (view SPL)rOPINIRole Tablets USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-02-252681514072
73683d5bf-0159-4a81-ba37-f5ef448afdd7 (view SPL)REQUIP (ropinirole tablets)Patient Information IncludedprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-08-256552890470
83d4ea23a-c4d9-4983-94e7-b76ed752a641 (view SPL)Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information IncludedprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-291000636294971
9414cd6c4-4926-4dfc-93c4-f04f4b7eeac3 (view SPL)Ropinirole Tablets, USPprescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2013-03-052556480154
10417964dc-94c1-475e-b954-9d3e6fcba0e0 (view SPL)rOPINIRole Tablets USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-02-252681514071
114c88de4d-64b8-43e1-9dbe-c38eede024a8 (view SPL)rOPINIRole Tablets USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-06-101433530911, 433530912, 433530920
125525c364-3574-4029-89dc-1efc6d85c03c (view SPL)Ropinirole Hydrochloride TabletsprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-05-023658410712
135f704e82-0c0f-4df9-b221-f8982b318ee2 (view SPL)REQUIP ( ropinirole tablets) Patient Information IncludedprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636293760
146f7fc849-8a38-47a1-bc39-54801a86416c (view SPL)Ropinirole Hydrochloride TabletsprescriptionHuman PrescriptionZhejiang Huahai Pharmaceutical Co., Ltd.MANUFACTURE2011-09-142642200420, 642200421, 642200422, 642200423, 642200424, 642200425, 642200426
157734ef0b-584f-42dd-a8b5-adbdf4e4df93 (view SPL)These highlights do not include all the information needed to use ropinirole hydrochloride tablets safely and effectively. See full prescribing information for ropinirole hydrochloride tablets.ROPINIROLE Hydrochloride Tablets, USP, film coated for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionSolco Healthcare U.S., Llc2015-11-169435470268, 435470269, 435470270, 435470271, 435470272, 435470273, 435470274
1685971b31-6f7d-421c-bf3c-5b33f3c1e781 (view SPL)These highlights do not include all the information needed to use ropinirole safely and effectively. See full prescribing information for ropinirole. ROPINIROLE tablets USP, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2014-11-306684620253, 684620254, 684620255, 684620256, 684620257, 684620258, 684620259
1788c5b939-a658-4972-b849-e5c00a447b53 (view SPL)Ropinirole Hydrochloride TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-06-301216950793
188e23aac9-446c-43b5-89ab-fc596b766df0 (view SPL)Ropinirole Hydrochloride Tablets, USP, film coatedprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231001636294798
199a25f575-09ab-4d32-b73e-5426f08c00c4 (view SPL)ROPINIROLE HYDROCHLORIDE- ropinirole hydrochloridetablet, film coatedAlembic Pharmaceuticals LimitedprescriptionHuman PrescriptionAlembic LimitedMANUFACTURE2013-09-131467080030, 467080031, 467080032, 467080033, 467080034, 467080035, 467080036
209a8eb66e-21fe-468d-aeec-44a8aa4c7869 (view SPL)ROPINIROLE HYDROCHLORIDE TABLETS5282528352845285528652875288Rx onlyprescriptionHuman PrescriptionMajorMANUFACTURE, REPACK2009-09-014009045994, 009045995, 009045996, 009045997, 009045998, 009045999, 009046000
21a543b4fb-186a-40f4-8c88-861b7db2b3e9 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-06-231165900643, 165900734
22b11ca8cb-289c-4015-84b3-be905de46aff (view SPL)Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information IncludedprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2015-03-261532170166
23b8fbd5b8-8797-4b95-b9a6-40a28a76805d (view SPL)Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information IncludedprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-291000636294977
24b9ff238b-1e7c-4663-aa70-81425d0ced9e (view SPL)These highlights do not include all the information needed to use ropinirole tablets safely and effectively.See full prescribing information for ropinirole tablets.ROPINIROLE tablets, USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-07-172680840195, 680840201, 680840311, 680840332
25bccd27a8-a65e-951c-1bbf-31f4dfe8a946 (view SPL)These highlights do not include all the information needed to use ROPINIROLE tablets, USP safely and effectively. See full prescribing information for ROPINIROLE tablets, USP. ROPINIROLE tablets, USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-10-103605052865, 605052866, 605052867, 605052868, 605052869, 605052870, 605052871
26bee2269a-22e8-413f-99bb-ea64169b4491 (view SPL)Ropinirole Hydrochloride TabletsprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-02-1412006157536, 006157537, 006157538, 006157539, 006157567
27c1c74e92-c34f-4ab7-b541-5ac0b738c846 (view SPL)Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information IncludedprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-08-142682587162
28c3b91380-1a23-4b44-bd1d-4888e43fe8b9 (view SPL)These highlights do not include all the information needed to use Ropinirole Hydrochloride Tablets safely and effectively. See full prescribing information for Ropinirole Hydrochloride Tablets. ROPINIROLE hydrochloride tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-09-165683820338
29caa8f322-325d-4117-a564-c87391ebf6fe (view SPL)rOPINIRole Tablets USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-313682587163
30cd4d1aeb-debf-458a-83c1-fa098d4d3415 (view SPL)These highlights do not include all the information needed to use ropinirole tablets safely and effectively. See full prescribing information for ropinirole tablets. ROPINIROLEtablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2015-11-1614231550121, 231550122, 231550123, 231550124, 231550125, 231550126, 231550127
31d52d231b-f407-f6a0-466e-0f714244010d (view SPL)Ropinirole Hydrochloride TabletsprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2009-09-181636293807
32de0bb94f-4fd8-4f27-5ba6-6f392dd5160f (view SPL)These highlights do not include all the information needed to use REQUIP safely and effectively. See full prescribing information for REQUIP.REQUIP(ropinirole) tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionGlaxosmithkline Llc2014-08-299000074890, 000074891, 000074892, 000074893, 000074894, 000074895, 000074896
33e05b026c-c46f-473a-b23c-56b463f95df1 (view SPL)These highlights do not include all the information needed to use rOPINIRole Tablets USP safely and effectively. See full prescribing information for rOPINIRole Tablets USP.rOPINIRole Tablets USP, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-10-165000540116, 000540117, 000540118, 000540119, 000540120, 000540121, 000540122
34e7ef58c0-73ba-4af2-b82b-a33954ec44df (view SPL)ROPINIROLE HYDROCHLORIDE- ropinirole hydrochloridetablet, film coatedAlembic Pharmaceuticals LimitedprescriptionHuman PrescriptionMajor2014-09-301009046373, 009046374
35ed314bc0-7ceb-441c-bf18-d24df66fbc5f (view SPL)ROPINIROLE HYDROCHLORIDE-ropinirole hydrochloride tablets, film coatedprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-02-151000636294641
36f1b2850e-097b-4a59-9c65-7cde77f30894 (view SPL)Ropinirole Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-07-052680840305, 680840306, 680840307, 680840308
37f37d8d11-ea44-4e45-a239-43f76316197e (view SPL)Ropinirole Tablets USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-03-261551547130
38f5ce07b9-ad0d-4b72-9daf-8662775af093 (view SPL)These highlights do not include all the information needed to use ropinirole tablets safely and effectively. See full prescribing information for ropinirole tablets.ROPINIROLE tablets, USP for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-0414003785501, 003785502, 003785503, 003785504, 003785505, 003785525, 003785550

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII