Glycopyrrolate Oral Tablet

Brand(s)
Glycate, Robinul
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shionogi Inc. (2011-12-01)
Oldest Current Product
1961-03-28
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\GLYCOPYRROLATE
FDAOB
ORAL\TABLET\GLYCOPYRROLATE
SPL Active
ORAL\TABLET\GLYCOPYRROLATE
SPL Moiety
ORAL\TABLET\GLYCOPYRROLATE
ORAL\TABLET\GLYCOPYRROLATE: GLYCOPYRRONIUM
ORAL\TABLET\GLYCOPYRRONIUM

product(s) by strength(s)

glycopyrrolate 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300200RobinulNDAShionogi Inc.1961-03-28GLYCOPYRROLATEORALTABLETNDA012827bd65ee5e-2000-423c-b0a6-72eb213455c4

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1006033180ANDAQualitest Pharmaceuticals2008-12-292017-05-31GLYCOPYRROLATEORALTABLETANDA040821a9fe52b4-9290-4e26-a142-1506572bc217
2131070014ANDAAurolife Pharma Llc2013-04-15GLYCOPYRROLATEORALTABLETANDA202675677f8495-a870-45b6-bb65-75b449f040ce
3498840065ANDAPar Pharmaceutical Companies, Inc.2006-09-26GLYCOPYRROLATEORALTABLETANDA0406531f266d77-4f9e-44c9-a000-2f8fea3ac80b
4551110648ANDADr. Reddy'S Laboratories Ltd2008-07-14GLYCOPYRROLATEORALTABLETANDA040847725529e8-9c4b-4108-690a-e4f391439736
5551110649ANDADr. Reddy'S Laboratories Ltd2008-07-14GLYCOPYRROLATEORALTABLETANDA040847725529e8-9c4b-4108-690a-e4f391439736
6633040210ANDARnabaxy Pharmaceuticals Inc.2009-08-18GLYCOPYRROLATEORALTABLETANDA0408444ec4e4e4-ce23-463b-9296-bff35b005632
7641250139ANDAExcellium Pharmaceutical Inc.2012-10-01GLYCOPYRROLATEORALTABLETANDA0901956899ae9d-5981-4f01-9e55-cd88a79bb209
8649800258ANDARising Pharmaceuticals, Inc.2008-12-29GLYCOPYRROLATEORALTABLETANDA04082142437ef9-31bf-41ce-ad11-7f8036543eb4
9690760475ANDAQuinn Pharmaceuticals, Llc2015-03-02GLYCOPYRROLATEORALTABLETANDA091182e1ded8e0-c05b-4bf4-a129-57d1726af6ed

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431250ANDAWest-Ward Pharmaceutical Corp2009-03-05GLYCOPYRROLATEORALTABLETANDA0408369690ebaf-be1b-4968-a578-28bd5372f022

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910303ANDAAvkare, Inc.2015-05-14GLYCOPYRROLATEORALTABLET641250139ANDA09019578a08c0f-5867-fd23-7534-40be7f0be961
2510790700ANDAMylan Institutional Inc.2010-06-14GLYCOPYRROLATEORALTABLET006033180ANDA040821a8fbd1e6-8722-42c0-9bb3-7876d1ca2cfd
3521250729ANDARemedyrepack Inc.2013-10-04GLYCOPYRROLATEORALTABLET006033180ANDA0408215d55f224-27b9-4a81-bf6c-d56d3d44a489
4521250731ANDARemedyrepack Inc.2013-10-04GLYCOPYRROLATEORALTABLET498840065ANDA0406531c63056b-27df-4b08-87c0-ecb8d4f665c0
5636295138ANDABryant Ranch Prepack2008-12-29GLYCOPYRROLATEORALTABLET006033180ANDA0408214c4924b9-f5b9-4f52-979a-ac0733aa5874
6680840499ANDAAmerican Health Packaging2011-09-01GLYCOPYRROLATEORALTABLET498840065ANDA040653b5650ad5-471d-4639-b8da-bdb3d990c627
7681510614ANDACarilion Materials Management2008-07-14GLYCOPYRROLATEORALTABLET551110648ANDA040847cab08105-b9bd-47df-8cb8-5c2cb3940d42

glycopyrrolate 1.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007227097ANDANexgen Pharma, Inc.2012-03-12GLYCOPYRROLATEORALTABLETANDA09152206bb6f89-4694-4aaa-8bff-f7f3c81d3add
2595470210GlycateANDANuro Pharma, Inc.2012-03-12GLYCOPYRROLATEORALTABLETANDA091522045baa49-d22c-4ed8-8dd6-b90565eca017

glycopyrrolate 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300205RobinulNDAShionogi Inc.1961-03-28GLYCOPYRROLATEORALTABLETNDA012827bd65ee5e-2000-423c-b0a6-72eb213455c4

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1006033181ANDAQualitest Pharmaceuticals2008-12-292017-06-30GLYCOPYRROLATEORALTABLETANDA040821a9fe52b4-9290-4e26-a142-1506572bc217
2498840066ANDAPar Pharmaceutical Companies, Inc.2006-09-26GLYCOPYRROLATEORALTABLETANDA0406531f266d77-4f9e-44c9-a000-2f8fea3ac80b
3633040211ANDARnabaxy Pharmaceuticals Inc.2009-08-18GLYCOPYRROLATEORALTABLETANDA0408444ec4e4e4-ce23-463b-9296-bff35b005632
4641250140ANDAExcellium Pharmaceutical Inc.2012-10-01GLYCOPYRROLATEORALTABLETANDA0901956899ae9d-5981-4f01-9e55-cd88a79bb209
5649800259ANDARising Pharmaceuticals, Inc.2008-12-29GLYCOPYRROLATEORALTABLETANDA04082142437ef9-31bf-41ce-ad11-7f8036543eb4
6690760476ANDAQuinn Pharmaceuticals, Llc2015-03-02GLYCOPYRROLATEORALTABLETANDA091182e1ded8e0-c05b-4bf4-a129-57d1726af6ed

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431251ANDAWest-Ward Pharmaceutical Corp2009-03-05GLYCOPYRROLATEORALTABLETANDA0408369690ebaf-be1b-4968-a578-28bd5372f022

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910304ANDAAvkare, Inc.2015-05-14GLYCOPYRROLATEORALTABLET641250140ANDA09019578a08c0f-5867-fd23-7534-40be7f0be961
2606870126ANDAAmerican Health Packaging2015-03-31GLYCOPYRROLATEORALTABLET006033181ANDA040821d447da02-f7bb-45b8-99d3-dd7ae49e6fd2
3606870187ANDAAmerican Health Packaging2015-11-16GLYCOPYRROLATEORALTABLET649800259ANDA04082149d5cb19-e386-44a7-b8d2-8a109f699155
4636295442ANDABryant Ranch Prepack2006-09-26GLYCOPYRROLATEORALTABLET498840065ANDA040653dcd7967d-770b-453c-9266-143106520f9e

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA040568GLYCOPYRROLATETrueCOREPHARMA LLC2004-12-22ANDA040568_001, ANDA040568_002
2ANDA040653GLYCOPYRROLATEPAR PHARMACEUTICAL INC2006-08-31ANDA040653_001, ANDA040653_002
3ANDA040821GLYCOPYRROLATEVINTAGE PHARMACEUTICALS LLC2008-12-29ANDA040821_001, ANDA040821_002
4ANDA040836GLYCOPYRROLATETrueHIKMA PHARMACEUTICALS LLC2009-03-05ANDA040836_001, ANDA040836_002
5ANDA040844GLYCOPYRROLATESUN PHARMACEUTICAL INDUSTRIES LTD2009-08-18ANDA040844_001, ANDA040844_002
6ANDA040847GLYCOPYRROLATEDR REDDYS LABORATORIES LTD2008-03-21ANDA040847_001, ANDA040847_002
7ANDA085562GLYCOPYRROLATETrueWATSON LABORATORIES INCANDA085562_001
8ANDA085563GLYCOPYRROLATETrueWATSON LABORATORIES INCANDA085563_001
9ANDA086178GLYCOPYRROLATETrueWATSON LABORATORIES INCANDA086178_001
10ANDA086900GLYCOPYRROLATETrueWATSON LABORATORIES INCANDA086900_001
11ANDA086902GLYCOPYRROLATETrueWATSON LABORATORIES INCANDA086902_001
12ANDA090020GLYCOPYRROLATEVINTAGE PHARMACEUTICALS2011-10-19ANDA090020_001, ANDA090020_002
13ANDA090195GLYCOPYRROLATELEADING PHARMA LLC2012-09-21ANDA090195_001, ANDA090195_002
14ANDA091182GLYCOPYRROLATESTASON PHARMACEUTICALS INC2014-02-03ANDA091182_001, ANDA091182_002
15ANDA091522GLYCOPYRROLATENEXGEN PHARMA INC2012-03-12ANDA091522_001
16ANDA202675GLYCOPYRROLATEAUROLIFE PHARMA LLC2013-04-15ANDA202675_001
17NDA012827ROBINULSHIONOGI INCp7091236, FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCERNDA012827_001, NDA012827_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040568_001discontinuedGLYCOPYRROLATE (1MG)ORALTABLETFalse2004-12-22GLYCOPYRROLATE
2ANDA040568_002discontinuedGLYCOPYRROLATE (2MG)ORALTABLETFalse2004-12-22GLYCOPYRROLATE
3ANDA040653_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2006-08-31GLYCOPYRROLATE
4ANDA040653_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2006-08-31GLYCOPYRROLATE
5ANDA040821_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2008-12-29GLYCOPYRROLATE
6ANDA040821_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2008-12-29GLYCOPYRROLATE
7ANDA040836_001discontinuedGLYCOPYRROLATE (1MG)ORALTABLETFalse2009-03-05GLYCOPYRROLATE
8ANDA040836_002discontinuedGLYCOPYRROLATE (2MG)ORALTABLETFalse2009-03-05GLYCOPYRROLATE
9ANDA040844_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2009-08-18GLYCOPYRROLATE
10ANDA040844_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2009-08-18GLYCOPYRROLATE
11ANDA040847_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2008-03-21GLYCOPYRROLATE
12ANDA040847_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2008-03-21GLYCOPYRROLATE
13ANDA085562_001discontinuedGLYCOPYRROLATE (1MG)ORALTABLETFalseGLYCOPYRROLATE
14ANDA085563_001discontinuedGLYCOPYRROLATE (2MG)ORALTABLETFalseGLYCOPYRROLATE
15ANDA086178_001discontinuedGLYCOPYRROLATE (2MG)ORALTABLETFalseGLYCOPYRROLATE
16ANDA086900_001discontinuedGLYCOPYRROLATE (2MG)ORALTABLETFalseGLYCOPYRROLATE
17ANDA086902_001discontinuedGLYCOPYRROLATE (1MG)ORALTABLETFalseGLYCOPYRROLATE
18ANDA090020_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2011-10-19GLYCOPYRROLATE
19ANDA090020_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2011-10-19GLYCOPYRROLATE
20ANDA090195_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2012-09-21GLYCOPYRROLATE
21ANDA090195_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2012-09-21GLYCOPYRROLATE
22ANDA091182_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2014-02-03GLYCOPYRROLATE
23ANDA091182_002RXGLYCOPYRROLATE (2MG)ORALTABLETFalseAA2014-02-03GLYCOPYRROLATE
24ANDA091522_001RXGLYCOPYRROLATE (1.5MG)ORALTABLETFalseAA2012-03-12GLYCOPYRROLATE
25ANDA202675_001RXGLYCOPYRROLATE (1MG)ORALTABLETFalseAA2013-04-15GLYCOPYRROLATE
26NDA012827_001RXGLYCOPYRROLATE (1MG)ORALTABLETTrueAAROBINUL
27NDA012827_002RXGLYCOPYRROLATE (2MG)ORALTABLETTrueAAROBINUL

patent(s)

#idexpiration dateapplication(s)
1p7091236 (view patent)2024-04-24NDA012827

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1045baa49-d22c-4ed8-8dd6-b90565eca017 (view SPL)Glycatetm (Glycopyrrolate Tablets, USP) 1.5 mgprescriptionHuman PrescriptionNuro Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-09-021595470210
206bb6f89-4694-4aaa-8bff-f7f3c81d3add (view SPL)GLYCOPYRROLATE TABLETS, USP 1.5 MGprescriptionHuman PrescriptionNexgen Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-03-121007227097
31c63056b-27df-4b08-87c0-ecb8d4f665c0 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-10-041521250731
41f266d77-4f9e-44c9-a000-2f8fea3ac80b (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2011-09-213498840065, 498840066
542437ef9-31bf-41ce-ad11-7f8036543eb4 (view SPL)GLYCOPYRROLATE TABLETS, USP 1 mg and 2 mgprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-09-142649800258, 649800259
649d5cb19-e386-44a7-b8d2-8a109f699155 (view SPL)GLYCOPYRROLATE TABLETS, USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-11-092606870187
74c4924b9-f5b9-4f52-979a-ac0733aa5874 (view SPL)GLYCOPYRROLATE TABLETS, USP 1 mg and 2 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081001636295138
84ec4e4e4-ce23-463b-9296-bff35b005632 (view SPL)GLYCOPYRROLATE TABLETS, USPRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2013-01-033633040210, 633040211
95d55f224-27b9-4a81-bf6c-d56d3d44a489 (view SPL)GLYCOPYRROLATE TABLETS, USP 1 mg and 2 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-041521250729
10677f8495-a870-45b6-bb65-75b449f040ce (view SPL)Glycopyrrolate Tablets, USPRx onlyprescriptionHuman PrescriptionAurolife Pharma LlcMANUFACTURE2013-06-063131070014
116899ae9d-5981-4f01-9e55-cd88a79bb209 (view SPL)Glycopyrrolate Tablets Rx OnlyprescriptionHuman PrescriptionExcellium Pharmaceutical Inc.MANUFACTURE2012-09-271641250139, 641250140
12725529e8-9c4b-4108-690a-e4f391439736 (view SPL)Glycopyrrolate TabletsprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2009-09-091551110648, 551110649
1378a08c0f-5867-fd23-7534-40be7f0be961 (view SPL)Glycopyrrolate Tablets Rx OnlyprescriptionHuman PrescriptionAvkare, Inc.2015-05-151422910303, 422910304
149690ebaf-be1b-4968-a578-28bd5372f022 (view SPL)Glycopyrrolate Tablets, USP Rx Only Revised 02/11prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2012-03-074001431250, 001431251
15a8fbd1e6-8722-42c0-9bb3-7876d1ca2cfd (view SPL)GLYCOPYRROLATE TABLETS, USP 1 mg and 2 mgprescriptionHuman PrescriptionMylan Institutional Inc.2012-10-054510790700
16a9fe52b4-9290-4e26-a142-1506572bc217 (view SPL)GLYCOPYRROLATE TABLETS, USP 1 mg and 2 mgprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-10-027006033180, 006033181
17b5650ad5-471d-4639-b8da-bdb3d990c627 (view SPL)GLYCOPYRROLATE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-062680840499
18bd65ee5e-2000-423c-b0a6-72eb213455c4 (view SPL)Robinul and Robinul ForteprescriptionHuman PrescriptionShionogi Inc.2011-12-017596300200, 596300205
19cab08105-b9bd-47df-8cb8-5c2cb3940d42 (view SPL)Glycopyrrolate TabletsprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2009-09-092681510614
20d447da02-f7bb-45b8-99d3-dd7ae49e6fd2 (view SPL)GLYCOPYRROLATE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-172606870126
21dcd7967d-770b-453c-9266-143106520f9e (view SPL)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-03-201001636295442
22e1ded8e0-c05b-4bf4-a129-57d1726af6ed (view SPL)GLYCOPYRROLATE TABLETS USP1 mg and 2 mgRx onlyprescriptionHuman PrescriptionQuinn Pharmaceuticals, Llcmanufacture2015-02-282690760475, 690760476

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