Propranolol Extended Release Oral Capsule

Brand(s)
Inderal, InnoPran
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akrimax Pharmaceuticals, Llc (2015-11-10)
Oldest Current Product
1983-04-19
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\PROPRANOLOL
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\PROPRANOLOL HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\PROPRANOLOL HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\PROPRANOLOL

product(s) by strength(s)

24 hr propranolol hydrochloride 120 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900451InnoPranNDAAkrimax Pharmaceuticals, Llc2013-06-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA0214384d15bb34-f5d0-4cd0-8b08-27a0c265d9a5
2240900473InderalNDAAkrimax Pharmaceuticals, Llc1983-04-19PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553fce692df-1e68-465e-8dda-0cb01320608c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282780ANDAActavis Elizabeth Llc2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078494a4edba76-29b8-41fb-bf0b-d4633abba003
2002450086ANDAUpsher-Smith Laboratories, Inc.2011-05-02PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078311a5efc305-2dd1-4946-a1f8-d149b014a484
3003786220ANDAMylan Pharmaceuticals Inc.2007-02-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA0780225255952a-841c-400c-8066-88ef7807590d
4426890013ANDANortec Development Associates, Inc2015-05-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078065b756f602-62c9-41ef-a934-834ac81b46ae
5434780902NDA AUTHORIZED GENERICRouses Point Pharm2009-02-25PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553c5091cd2-81c8-4ffe-b2aa-d053de5d6e12
6519910819ANDABreckenridge Pharmaceutical, Inc.2013-03-11PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078703179e31a7-9956-4fba-9e9a-2ca28d37d42b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1504360902NDA AUTHORIZED GENERICUnit Dose Services1983-04-19PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE434780902NDA018553e2f24efe-ff12-45f2-a4af-4f8ab3c9e835
2548681518ANDAPhysicians Total Care, Inc.1994-03-14PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE498840329ANDA078065e27c2424-0e18-4c10-aa3a-34bc28b5d681
3604290128ANDAGolden State Medical Supply, Inc.2014-07-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282780ANDA078494eeae39f6-9cea-4044-944c-8afe6713c0f2
4680840916NDA AUTHORIZED GENERICAmerican Health Packaging2015-10-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE434780902NDA018553fe2ba973-265f-4f3b-a8a8-17c82a35c70b

24 hr propranolol hydrochloride 160 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900479InderalNDAAkrimax Pharmaceuticals, Llc1983-04-19PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553fce692df-1e68-465e-8dda-0cb01320608c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282781ANDAActavis Elizabeth Llc2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078494a4edba76-29b8-41fb-bf0b-d4633abba003
2002450087ANDAUpsher-Smith Laboratories, Inc.2011-05-02PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078311a5efc305-2dd1-4946-a1f8-d149b014a484
3003786260ANDAMylan Pharmaceuticals Inc.2007-02-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA0780225255952a-841c-400c-8066-88ef7807590d
4426890014ANDANortec Development Associates, Inc2015-05-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078065b756f602-62c9-41ef-a934-834ac81b46ae
5434780903NDA AUTHORIZED GENERICRouses Point Pharm2009-02-25PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553c5091cd2-81c8-4ffe-b2aa-d053de5d6e12
6519910820ANDABreckenridge Pharmaceutical, Inc.2013-03-11PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078703179e31a7-9956-4fba-9e9a-2ca28d37d42b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680854ANDAPhysicians Total Care, Inc.2007-05-02PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE498840330ANDA078065e27c2424-0e18-4c10-aa3a-34bc28b5d681
2557000121ANDALake Erie Medical Dba Quality Care Products Llc2013-03-11PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE519910820ANDA078703120eb1c5-21dc-4f25-96db-ba2dd61e1048
3604290129ANDAGolden State Medical Supply, Inc.2014-07-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282781ANDA078494eeae39f6-9cea-4044-944c-8afe6713c0f2
4680840932NDA AUTHORIZED GENERICAmerican Health Packaging2015-10-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE434780903NDA018553fe2ba973-265f-4f3b-a8a8-17c82a35c70b

24 hr propranolol hydrochloride 60 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900470InderalNDAAkrimax Pharmaceuticals, Llc1983-04-19PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553fce692df-1e68-465e-8dda-0cb01320608c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282778ANDAActavis Elizabeth Llc2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078494a4edba76-29b8-41fb-bf0b-d4633abba003
2002450084ANDAUpsher-Smith Laboratories, Inc.2011-05-02PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078311a5efc305-2dd1-4946-a1f8-d149b014a484
3003786160ANDAMylan Pharmaceuticals Inc.2007-02-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA0780225255952a-841c-400c-8066-88ef7807590d
4426890011ANDANortec Development Associates, Inc2015-05-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078065b756f602-62c9-41ef-a934-834ac81b46ae
5434780900NDA AUTHORIZED GENERICRouses Point Pharm2009-02-25PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553c5091cd2-81c8-4ffe-b2aa-d053de5d6e12
6519910817ANDABreckenridge Pharmaceutical, Inc.2013-03-11PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078703179e31a7-9956-4fba-9e9a-2ca28d37d42b
7658410745ANDACadila Healthcare Limited2014-04-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA090321fa1ec93e-35b0-43c9-81ee-69f7e8abea87
8683820161ANDAZydus Pharmaceuticals (Usa) Inc.2014-04-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA0903215a7858eb-9d2d-44d9-9f81-c78ba3ce1815

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490278ANDARemedyrepack Inc.2011-06-03PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282778ANDA0784941431ca79-5995-46c2-a16f-882ed7bc43ca
2504364315ANDAUnit Dose Services2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282778ANDA078494fc3c4c5e-b21f-428e-9ee9-88b478f39998
3548681517ANDAPhysicians Total Care, Inc.2007-03-30PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE498840282ANDA078065e27c2424-0e18-4c10-aa3a-34bc28b5d681
4604290126ANDAGolden State Medical Supply, Inc.2014-07-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282778ANDA078494eeae39f6-9cea-4044-944c-8afe6713c0f2
5636291842ANDABryant Ranch Prepack2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282778ANDA0784940edd2792-281e-463f-a564-ab8969e812d9
6680840503NDA AUTHORIZED GENERICAmerican Health Packaging2013-07-05PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE434780900NDA01855370e029d2-0a8d-4a6b-bdf6-59bbe58bd659
7681513071ANDACarilion Materials Management2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282778ANDA07849437438047-b456-4e85-a7cc-3eb688908cfe

24 hr propranolol hydrochloride 80 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900450InnoPranNDAAkrimax Pharmaceuticals, Llc2013-06-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA0214384d15bb34-f5d0-4cd0-8b08-27a0c265d9a5
2240900471InderalNDAAkrimax Pharmaceuticals, Llc1983-04-19PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553fce692df-1e68-465e-8dda-0cb01320608c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282779ANDAActavis Elizabeth Llc2007-08-10PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078494a4edba76-29b8-41fb-bf0b-d4633abba003
2002450085ANDAUpsher-Smith Laboratories, Inc.2011-05-02PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078311a5efc305-2dd1-4946-a1f8-d149b014a484
3003786180ANDAMylan Pharmaceuticals Inc.2007-02-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA0780225255952a-841c-400c-8066-88ef7807590d
4426890012ANDANortec Development Associates, Inc2015-05-01PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078065b756f602-62c9-41ef-a934-834ac81b46ae
5434780901NDA AUTHORIZED GENERICRouses Point Pharm2009-02-25PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA018553c5091cd2-81c8-4ffe-b2aa-d053de5d6e12
6519910818ANDABreckenridge Pharmaceutical, Inc.2013-03-11PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASEANDA078703179e31a7-9956-4fba-9e9a-2ca28d37d42b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440286NDA AUTHORIZED GENERICBlenheim Pharmacal, Inc.2013-11-18PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE434780901NDA0185530fc60597-a43b-1a0f-e054-00144ff88e88
2493490420ANDARemedyrepack Inc.2011-07-28PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282779ANDA07849476622d52-a8f5-439e-b983-b9ba712e02e4
3548681078ANDAPhysicians Total Care, Inc.2013-06-27PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282779ANDA078494ddc8b010-61e1-466f-9dc6-91001000c0f5
4548685755ANDAPhysicians Total Care, Inc.2007-02-05PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE498840328ANDA078065e27c2424-0e18-4c10-aa3a-34bc28b5d681
5604290127ANDAGolden State Medical Supply, Inc.2014-07-15PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE002282779ANDA078494eeae39f6-9cea-4044-944c-8afe6713c0f2
6680840504NDA AUTHORIZED GENERICAmerican Health Packaging2013-07-05PROPRANOLOL HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASE434780901NDA01855370e029d2-0a8d-4a6b-bdf6-59bbe58bd659

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA072499PROPRANOLOL HYDROCHLORIDETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1989-04-11ANDA072499_001
2ANDA072500PROPRANOLOL HYDROCHLORIDETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1989-04-11ANDA072500_001
3ANDA072501PROPRANOLOL HYDROCHLORIDETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1989-04-11ANDA072501_001
4ANDA072502PROPRANOLOL HYDROCHLORIDETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1989-04-11ANDA072502_001
5ANDA078022PROPRANOLOL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2007-02-15ANDA078022_001, ANDA078022_002, ANDA078022_003, ANDA078022_004
6ANDA078065PROPRANOLOL HYDROCHLORIDENORTEC DEVELOPMENT ASSOC INC2007-01-26ANDA078065_001, ANDA078065_002, ANDA078065_003, ANDA078065_004
7ANDA078311PROPRANOLOL HYDROCHLORIDEUPSHER SMITH LABORATORIES INC2009-03-06ANDA078311_001, ANDA078311_002, ANDA078311_003, ANDA078311_004
8ANDA078494PROPRANOLOL HYDROCHLORIDEACTAVIS ELIZABETH LLC2007-08-10ANDA078494_001, ANDA078494_002, ANDA078494_003, ANDA078494_004
9ANDA078703PROPRANOLOL HYDROCHLORIDERP SCHERER TECHNOLOGIES LLC2011-07-15ANDA078703_001, ANDA078703_002, ANDA078703_003, ANDA078703_004
10ANDA090321PROPRANOLOL HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2011-03-25ANDA090321_001, ANDA090321_002, ANDA090321_003, ANDA090321_004
11NDA018553INDERAL LACRANFORD PHARMACEUTICALS LLC1983-04-19NDA018553_001, NDA018553_002, NDA018553_003, NDA018553_004
12NDA021438INNOPRAN XLGLAXOSMITHKLINE LLC2003-03-12p6500454, SUBSTANCENDA021438_001, NDA021438_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072499_001discontinuedPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-04-11PROPRANOLOL HYDROCHLORIDE
2ANDA072500_001discontinuedPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-04-11PROPRANOLOL HYDROCHLORIDE
3ANDA072501_001discontinuedPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-04-11PROPRANOLOL HYDROCHLORIDE
4ANDA072502_001discontinuedPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-04-11PROPRANOLOL HYDROCHLORIDE
5ANDA078022_001RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-02-15PROPRANOLOL HYDROCHLORIDE
6ANDA078022_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-02-15PROPRANOLOL HYDROCHLORIDE
7ANDA078022_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-02-15PROPRANOLOL HYDROCHLORIDE
8ANDA078022_004RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-02-15PROPRANOLOL HYDROCHLORIDE
9ANDA078065_001RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-01-26PROPRANOLOL HYDROCHLORIDE
10ANDA078065_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-01-26PROPRANOLOL HYDROCHLORIDE
11ANDA078065_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-01-26PROPRANOLOL HYDROCHLORIDE
12ANDA078065_004RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-01-26PROPRANOLOL HYDROCHLORIDE
13ANDA078311_001RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-03-06PROPRANOLOL HYDROCHLORIDE
14ANDA078311_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-03-06PROPRANOLOL HYDROCHLORIDE
15ANDA078311_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-03-06PROPRANOLOL HYDROCHLORIDE
16ANDA078311_004RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-03-06PROPRANOLOL HYDROCHLORIDE
17ANDA078494_001RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-08-10PROPRANOLOL HYDROCHLORIDE
18ANDA078494_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-08-10PROPRANOLOL HYDROCHLORIDE
19ANDA078494_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-08-10PROPRANOLOL HYDROCHLORIDE
20ANDA078494_004RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2007-08-10PROPRANOLOL HYDROCHLORIDE
21ANDA078703_001RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-07-15PROPRANOLOL HYDROCHLORIDE
22ANDA078703_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-07-15PROPRANOLOL HYDROCHLORIDE
23ANDA078703_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-07-15PROPRANOLOL HYDROCHLORIDE
24ANDA078703_004RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-07-15PROPRANOLOL HYDROCHLORIDE
25ANDA090321_001RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-03-25PROPRANOLOL HYDROCHLORIDE
26ANDA090321_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-03-25PROPRANOLOL HYDROCHLORIDE
27ANDA090321_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-03-25PROPRANOLOL HYDROCHLORIDE
28ANDA090321_004RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2011-03-25PROPRANOLOL HYDROCHLORIDE
29NDA018553_001RXPROPRANOLOL HYDROCHLORIDE (160MG)ORALCAPSULE, EXTENDED RELEASETrueAB1983-04-19INDERAL LA
30NDA018553_002RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB1983-04-19INDERAL LA
31NDA018553_003RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseAB1983-04-19INDERAL LA
32NDA018553_004RXPROPRANOLOL HYDROCHLORIDE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB1987-03-18INDERAL LA
33NDA021438_001RXPROPRANOLOL HYDROCHLORIDE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseBX2003-03-12INNOPRAN XL
34NDA021438_002RXPROPRANOLOL HYDROCHLORIDE (120MG)ORALCAPSULE, EXTENDED RELEASEFalseBX2003-03-12INNOPRAN XL

patent(s)

#idexpiration dateapplication(s)
1p6500454 (view patent)2021-10-04NDA021438

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10edd2792-281e-463f-a564-ab8969e812d9 (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636291842
20fc60597-a43b-1a0f-e054-00144ff88e88 (view SPL)Propranolol hydrochloride extended-release capsulesprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-04-093105440286
3120eb1c5-21dc-4f25-96db-ba2dd61e1048 (view SPL)Propranolol Hydrochloride Extended-Release Capsules, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2015-04-301557000121
41431ca79-5995-46c2-a16f-882ed7bc43ca (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-031493490278
5179e31a7-9956-4fba-9e9a-2ca28d37d42b (view SPL)Propranolol Hydrochloride Extended-Release Capsules, USPprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE, PACK2014-09-033519910817, 519910818, 519910819, 519910820
637438047-b456-4e85-a7cc-3eb688908cfe (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-06-202681513071
74d15bb34-f5d0-4cd0-8b08-27a0c265d9a5 (view SPL)These highlights do not include all the information needed to use INNOPRAN XL safely and effectively. See full prescribing information for INNOPRAN XL. INNOPRAN XL (propranolol hydrochloride) extended release capsules, for oral use Initial U.S. Approval: 2003prescriptionHuman PrescriptionAkrimax Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2013-11-018240900450, 240900451
85255952a-841c-400c-8066-88ef7807590d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-05-314003786160, 003786180, 003786220, 003786260
95a7858eb-9d2d-44d9-9f81-c78ba3ce1815 (view SPL)Propranolol Hydrochloride Extended-release Capsules, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-04-081683820161
1070e029d2-0a8d-4a6b-bdf6-59bbe58bd659 (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 8250301/1214 Rx onlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-195680840503, 680840504
1176622d52-a8f5-439e-b983-b9ba712e02e4 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-281493490420
1284050954-e94c-4d90-b3b3-6f47fd14e492 (view SPL)These highlights do not include all the information needed to use INDERAL XL safely and effectively. See full prescribing information for INDERAL XL. INDERAL XL (propranolol hydrochloride) extended-release capsules, for oral use Initial U.S. Approval: 2003prescriptionHuman PrescriptionMist Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE, PACK2013-11-0113762990420, 762990422
13a4edba76-29b8-41fb-bf0b-d4633abba003 (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, MANUFACTURE, PACK2012-06-204002282778, 002282779, 002282780, 002282781
14a5efc305-2dd1-4946-a1f8-d149b014a484 (view SPL)Propranolol Hydrochloride Extended-release Capsules, USPprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-10-078002450084, 002450085, 002450086, 002450087
15b756f602-62c9-41ef-a934-834ac81b46ae (view SPL)Rx OnlyprescriptionHuman PrescriptionNortec Development Associates, Incmanufacture2015-04-241426890011, 426890012, 426890013, 426890014
16c5091cd2-81c8-4ffe-b2aa-d053de5d6e12 (view SPL)Propranolol hydrochlorideprescriptionHuman PrescriptionRouses Point PharmAPI MANUFACTURE2015-11-0914434780900, 434780901, 434780902, 434780903
17ddc8b010-61e1-466f-9dc6-91001000c0f5 (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-11-251548681078
18e27c2424-0e18-4c10-aa3a-34bc28b5d681 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-093548680854, 548681517, 548681518, 548685755
19e2f24efe-ff12-45f2-a4af-4f8ab3c9e835 (view SPL)Propranolol hydrochloride extended-release capsulesprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-06-152504360902
20eeae39f6-9cea-4044-944c-8afe6713c0f2 (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-311604290126, 604290127, 604290128, 604290129
21fa1ec93e-35b0-43c9-81ee-69f7e8abea87 (view SPL)Propranolol Hydrochloride Extended-release Capsules, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2014-04-301658410745
22fc3c4c5e-b21f-428e-9ee9-88b478f39998 (view SPL)PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-06-012504364315
23fce692df-1e68-465e-8dda-0cb01320608c (view SPL)Inderal LAprescriptionHuman PrescriptionAkrimax Pharmaceuticals, LlcAPI MANUFACTURE2015-11-1014240900470, 240900471, 240900473, 240900479
24fe2ba973-265f-4f3b-a8a8-17c82a35c70b (view SPL)Propranolol Hydrochloride Extended-Release CapsulesprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-291680840916, 680840932

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