Nitroglycerin Transdermal Patch

Brand(s)
Minitran, Nitro-Dur
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2014-10-02)
Oldest Current Product
1995-04-04
License(s)
NDA, ANDA
RxNORM
TRANSDERMAL PATCH\NITROGLYCERIN
FDAOB
TRANSDERMAL\FILM, EXTENDED RELEASE\NITROGLYCERIN
SPL Active
TRANSDERMAL\FILM, EXTENDED RELEASE\NITROGLYCERIN
TRANSDERMAL\PATCH\NITROGLYCERIN
SPL Moiety
TRANSDERMAL\FILM, EXTENDED RELEASE\NITROGLYCERIN
TRANSDERMAL\PATCH\NITROGLYCERIN

product(s) by strength(s)

24 hr nitroglycerin 0.1 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000853305Nitro-DurNDAMerck Sharp & Dohme Corp.1995-04-04NITROGLYCERINTRANSDERMALPATCHNDA0201455de5366c-0719-4a4c-9483-cd99b218ee78

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789102ANDAMylan Pharmaceuticals Inc.1998-06-18NITROGLYCERINTRANSDERMALPATCHANDA074559e98a2692-1cb9-4994-98d8-1d8d9ef1a256
2293360301MinitranANDAGraceway Pharmaceuticals, Llc2007-04-01NITROGLYCERINTRANSDERMALPATCHANDA089771b17f29ca-517e-4d89-84f1-024d98fc5d77
3293360321ANDAGraceway Pharmaceuticals, Llc2007-04-01NITROGLYCERINTRANSDERMALPATCHANDA089771fcd4cf8a-e3e6-7da9-6355-c60b7400291a
4477810296ANDAAlvogen, Inc.2010-11-10NITROGLYCERINTRANSDERMALPATCHANDA0897716117ec32-636c-2304-e6dc-f622b058ae1d
5992070170MinitranANDAMedicis, The Dermatology Company2012-02-21NITROGLYCERINTRANSDERMALPATCHANDA08977115b3ea32-3422-4aa8-b4c2-41ee6d1aa566

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683115ANDAPhysicians Total Care, Inc.2006-05-30NITROGLYCERINTRANSDERMALPATCH293360321ANDA08977121679c9c-27d7-47c9-828e-b4cc405816cc

24 hr nitroglycerin 0.2 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000853310Nitro-DurNDAMerck Sharp & Dohme Corp.1995-04-04NITROGLYCERINTRANSDERMALPATCHNDA0201455de5366c-0719-4a4c-9483-cd99b218ee78

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789104ANDAMylan Pharmaceuticals Inc.1996-08-30NITROGLYCERINTRANSDERMALPATCHANDA074559e98a2692-1cb9-4994-98d8-1d8d9ef1a256
2009045495ANDAMajor1998-10-30NITROGLYCERINTRANSDERMALPATCHANDA0898844d7c7bf5-0f70-4a76-870c-f609d98e5ba9
3293360302MinitranANDAGraceway Pharmaceuticals, Llc2007-04-01NITROGLYCERINTRANSDERMALPATCHANDA089772b17f29ca-517e-4d89-84f1-024d98fc5d77
4293360322ANDAGraceway Pharmaceuticals, Llc2007-04-01NITROGLYCERINTRANSDERMALPATCHANDA089772fcd4cf8a-e3e6-7da9-6355-c60b7400291a
5477810297ANDAAlvogen, Inc.2010-11-10NITROGLYCERINTRANSDERMALPATCHANDA0897726117ec32-636c-2304-e6dc-f622b058ae1d
6497300111ANDAHercon Laboratories Corporation1998-10-30NITROGLYCERINTRANSDERMALPATCHANDA089884efb1e4fc-73b8-43c5-ac68-d5b870cc8e10
7992070171MinitranANDAMedicis, The Dermatology Company2012-02-21NITROGLYCERINTRANSDERMALPATCHANDA08977215b3ea32-3422-4aa8-b4c2-41ee6d1aa566

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1621750123ANDAKremers Urban Pharmaceuticals Inc.2004-08-10NITROGLYCERINTRANSDERMALFILM, EXTENDED RELEASEANDA075115a1648bd9-8a89-4292-b703-aa83d9bd6c6d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682183ANDAPhysicians Total Care, Inc.2004-10-12NITROGLYCERINTRANSDERMALPATCH293360322ANDA08977221679c9c-27d7-47c9-828e-b4cc405816cc
2551542625ANDACardinal Health1998-10-30NITROGLYCERINTRANSDERMALPATCH497300111ANDA0898842ce8c8f1-f0b7-45df-a531-42dbd9f2e56c

24 hr nitroglycerin 0.3 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000853315Nitro-DurNDAMerck Sharp & Dohme Corp.1995-04-04NITROGLYCERINTRANSDERMALPATCHNDA0201455de5366c-0719-4a4c-9483-cd99b218ee78

24 hr nitroglycerin 0.4 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000853320Nitro-DurNDAMerck Sharp & Dohme Corp.1995-04-04NITROGLYCERINTRANSDERMALPATCHNDA0201455de5366c-0719-4a4c-9483-cd99b218ee78

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789112ANDAMylan Pharmaceuticals Inc.1996-08-30NITROGLYCERINTRANSDERMALPATCHANDA074559e98a2692-1cb9-4994-98d8-1d8d9ef1a256
2009045496ANDAMajor1998-10-30NITROGLYCERINTRANSDERMALPATCHANDA0898854d7c7bf5-0f70-4a76-870c-f609d98e5ba9
3293360303MinitranANDAGraceway Pharmaceuticals, Llc2009-08-10NITROGLYCERINTRANSDERMALPATCHANDA089773b17f29ca-517e-4d89-84f1-024d98fc5d77
4293360323ANDAGraceway Pharmaceuticals, Llc2007-04-04NITROGLYCERINTRANSDERMALPATCHANDA089773fcd4cf8a-e3e6-7da9-6355-c60b7400291a
5477810298ANDAAlvogen, Inc.2010-11-10NITROGLYCERINTRANSDERMALPATCHANDA0897736117ec32-636c-2304-e6dc-f622b058ae1d
6497300112ANDAHercon Laboratories Corporation1998-10-30NITROGLYCERINTRANSDERMALPATCHANDA089885efb1e4fc-73b8-43c5-ac68-d5b870cc8e10
7992070172MinitranANDAMedicis, The Dermatology Company2012-02-21NITROGLYCERINTRANSDERMALPATCHANDA08977315b3ea32-3422-4aa8-b4c2-41ee6d1aa566

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1621750124ANDAKremers Urban Pharmaceuticals Inc.2004-08-10NITROGLYCERINTRANSDERMALFILM, EXTENDED RELEASEANDA075115a1648bd9-8a89-4292-b703-aa83d9bd6c6d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681992ANDAPhysicians Total Care, Inc.2004-10-27NITROGLYCERINTRANSDERMALPATCH293360323ANDA08977321679c9c-27d7-47c9-828e-b4cc405816cc

24 hr nitroglycerin 0.6 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000853330Nitro-DurNDAMerck Sharp & Dohme Corp.1995-04-04NITROGLYCERINTRANSDERMALPATCHNDA0201455de5366c-0719-4a4c-9483-cd99b218ee78

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789116ANDAMylan Pharmaceuticals Inc.1996-08-30NITROGLYCERINTRANSDERMALPATCHANDA074559e98a2692-1cb9-4994-98d8-1d8d9ef1a256
2009045497ANDAMajor1998-10-30NITROGLYCERINTRANSDERMALPATCHANDA0898864d7c7bf5-0f70-4a76-870c-f609d98e5ba9
3293360304MinitranANDAGraceway Pharmaceuticals, Llc2007-04-01NITROGLYCERINTRANSDERMALPATCHANDA089774b17f29ca-517e-4d89-84f1-024d98fc5d77
4293360324ANDAGraceway Pharmaceuticals, Llc2007-04-01NITROGLYCERINTRANSDERMALPATCHANDA089774fcd4cf8a-e3e6-7da9-6355-c60b7400291a
5477810299ANDAAlvogen, Inc.2010-11-10NITROGLYCERINTRANSDERMALPATCHANDA0897746117ec32-636c-2304-e6dc-f622b058ae1d
6497300113ANDAHercon Laboratories Corporation1998-10-30NITROGLYCERINTRANSDERMALPATCHANDA089886efb1e4fc-73b8-43c5-ac68-d5b870cc8e10
7992070173MinitranANDAMedicis, The Dermatology Company2012-02-21NITROGLYCERINTRANSDERMALPATCHANDA08977415b3ea32-3422-4aa8-b4c2-41ee6d1aa566

24 hr nitroglycerin 0.8 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000850819Nitro-DurNDAMerck Sharp & Dohme Corp.1995-04-04NITROGLYCERINTRANSDERMALPATCHNDA0201455de5366c-0719-4a4c-9483-cd99b218ee78

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074559NITROGLYCERINMYLAN TECHNOLOGIES INC1996-08-30ANDA074559_001, ANDA074559_002, ANDA074559_003, ANDA074559_004
2ANDA074992NITROGLYCERINTrueMYLAN TECHNOLOGIES INC1999-11-12ANDA074992_001, ANDA074992_002, ANDA074992_003, ANDA074992_004
3ANDA075115NITROGLYCERINTrueKREMERS URBAN PHARMACEUTICALS INC2004-08-10ANDA075115_001, ANDA075115_002
4ANDA089771MINITRANVALEANT PHARMACEUTICALS NORTH AMERICA LLC1996-08-30ANDA089771_001
5ANDA089772MINITRANMEDICIS PHARMACEUTICAL CORP1996-08-30ANDA089772_001
6ANDA089773MINITRANMEDICIS PHARMACEUTICAL CORP1996-08-30ANDA089773_001
7ANDA089774MINITRANVALEANT PHARMACEUTICALS NORTH AMERICA LLC1996-08-30ANDA089774_001
8ANDA089884NITROGLYCERINHERCON PHARMACEUTICAL LLC1998-10-30ANDA089884_001
9ANDA089885NITROGLYCERINHERCON PHARMACEUTICAL LLC1998-10-30ANDA089885_001
10ANDA089886NITROGLYCERINHERCON PHARMACEUTICAL LLC1998-10-30ANDA089886_001
11NDA020144TRANSDERM-NITROTrueNOVARTIS PHARMACEUTICALS CORP1996-02-27NDA020144_001, NDA020144_002, NDA020144_003, NDA020144_004, NDA020144_005
12NDA020145NITRO-DURMERCK SHARP AND DOHME CORP1995-04-04NDA020145_001, NDA020145_002, NDA020145_003, NDA020145_004, NDA020145_005, NDA020145_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074559_001RXNITROGLYCERIN (0.6MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB21996-08-30NITROGLYCERIN
2ANDA074559_002RXNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB21996-08-30NITROGLYCERIN
3ANDA074559_003RXNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB21996-08-30NITROGLYCERIN
4ANDA074559_004RXNITROGLYCERIN (0.1MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrue1998-02-06NITROGLYCERIN
5ANDA074992_001discontinuedNITROGLYCERIN (0.6MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-11-12NITROGLYCERIN
6ANDA074992_002discontinuedNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-11-12NITROGLYCERIN
7ANDA074992_003discontinuedNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-11-12NITROGLYCERIN
8ANDA074992_004discontinuedNITROGLYCERIN (0.1MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-11-12NITROGLYCERIN
9ANDA075115_001discontinuedNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2004-08-10NITROGLYCERIN
10ANDA075115_002discontinuedNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2004-08-10NITROGLYCERIN
11ANDA089771_001RXNITROGLYCERIN (0.1MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11996-08-30MINITRAN
12ANDA089772_001RXNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11996-08-30MINITRAN
13ANDA089773_001RXNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11996-08-30MINITRAN
14ANDA089774_001RXNITROGLYCERIN (0.6MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11996-08-30MINITRAN
15ANDA089884_001RXNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB21998-10-30NITROGLYCERIN
16ANDA089885_001RXNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB21998-10-30NITROGLYCERIN
17ANDA089886_001RXNITROGLYCERIN (0.6MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB21998-10-30NITROGLYCERIN
18NDA020144_001discontinuedNITROGLYCERIN (0.1MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1996-02-27TRANSDERM-NITRO
19NDA020144_002discontinuedNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1996-02-27TRANSDERM-NITRO
20NDA020144_003discontinuedNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1996-02-27TRANSDERM-NITRO
21NDA020144_004discontinuedNITROGLYCERIN (0.6MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1996-02-27TRANSDERM-NITRO
22NDA020144_005discontinuedNITROGLYCERIN (0.8MG/HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1996-02-27TRANSDERM-NITRO
23NDA020145_001RXNITROGLYCERIN (0.1MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB11995-04-04NITRO-DUR
24NDA020145_002RXNITROGLYCERIN (0.2MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB11995-04-04NITRO-DUR
25NDA020145_003RXNITROGLYCERIN (0.3MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrue1995-04-04NITRO-DUR
26NDA020145_004RXNITROGLYCERIN (0.4MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB11995-04-04NITRO-DUR
27NDA020145_005RXNITROGLYCERIN (0.6MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB11995-04-04NITRO-DUR
28NDA020145_006RXNITROGLYCERIN (0.8MG/HR)TRANSDERMALFILM, EXTENDED RELEASETrue1995-04-04NITRO-DUR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115b3ea32-3422-4aa8-b4c2-41ee6d1aa566 (view SPL)prescriptionHuman PrescriptionMedicis, The Dermatology CompanyMANUFACTURE2015-02-272992070170, 992070171, 992070172, 992070173
221679c9c-27d7-47c9-828e-b4cc405816cc (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-11-181548681992, 548682183, 548683115
32ce8c8f1-f0b7-45df-a531-42dbd9f2e56c (view SPL)NitroglycerinTransdermalSystemprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-221551542625
44d7c7bf5-0f70-4a76-870c-f609d98e5ba9 (view SPL)NitroglycerinTransdermalSystemprescriptionHuman PrescriptionMajorMANUFACTURE2010-04-081009045495, 009045496, 009045497
55de5366c-0719-4a4c-9483-cd99b218ee78 (view SPL)NITRO-DUR (nitroglycerin) Transdermal Infusion SystemprescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2014-10-024000850819, 000853305, 000853310, 000853315, 000853320, 000853330
66117ec32-636c-2304-e6dc-f622b058ae1d (view SPL)NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEMprescriptionHuman PrescriptionAlvogen, Inc.MANUFACTURE2015-02-264477810296, 477810297, 477810298, 477810299
7a1648bd9-8a89-4292-b703-aa83d9bd6c6d (view SPL)Nitroglycerin Transdermal SystemprescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.MANUFACTURE2011-02-013621750123, 621750124
8b17f29ca-517e-4d89-84f1-024d98fc5d77 (view SPL)prescriptionHuman PrescriptionGraceway Pharmaceuticals, LlcMANUFACTURE2006-01-045293360301, 293360302, 293360303, 293360304
9e98a2692-1cb9-4994-98d8-1d8d9ef1a256 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-11-037003789102, 003789104, 003789112, 003789116
10efb1e4fc-73b8-43c5-ac68-d5b870cc8e10 (view SPL)NitroglycerinTransdermalSystemprescriptionHuman PrescriptionHercon Laboratories CorporationMANUFACTURE2010-04-082497300111, 497300112, 497300113
11fcd4cf8a-e3e6-7da9-6355-c60b7400291a (view SPL)prescriptionHuman PrescriptionGraceway Pharmaceuticals, LlcMANUFACTURE2009-11-183293360321, 293360322, 293360323, 293360324

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