Nitroglycerin Sublingual Tablet

Brand(s)
Nitrostat
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Parke-Davis Div Of Pfizer Inc (2014-04-21)
Oldest Current Product
1994-09-22
License(s)
NDA, NDA AUTHORIZED GENERIC, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
SUBLINGUAL TABLET\NITROGLYCERIN
FDAOB
SUBLINGUAL\TABLET\NITROGLYCERIN
SPL Active
ORAL\TABLET\NITROGLYCERIN
SUBLINGUAL\TABLET, ORALLY DISINTEGRATING\NITROGLYCERIN
SUBLINGUAL\TABLET\NITROGLYCERIN
SPL Moiety
ORAL\TABLET\NITROGLYCERIN
SUBLINGUAL\TABLET, ORALLY DISINTEGRATING\NITROGLYCERIN
SUBLINGUAL\TABLET\NITROGLYCERIN

product(s) by strength(s)

nitroglycerin 0.3 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710417NitrostatNDAParke-Davis Div Of Pfizer Inc2000-05-01NITROGLYCERINSUBLINGUALTABLETNDA02113479ba021e-183c-4b4d-822e-4ff5ef54ca61

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597624921NDA AUTHORIZED GENERICGreenstone Llc2003-04-08NITROGLYCERINSUBLINGUALTABLET, ORALLY DISINTEGRATINGNDA021134041f127e-5166-4484-bc1a-0a373d1187ae

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681538NitrostatNDAPhysicians Total Care, Inc.1994-09-22NITROGLYCERINORALTABLET000710417NDA021134b32d82ee-7727-4501-a858-a8304135b11b

nitroglycerin 0.4 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710418NitrostatNDAParke-Davis Div Of Pfizer Inc2000-05-01NITROGLYCERINSUBLINGUALTABLETNDA02113479ba021e-183c-4b4d-822e-4ff5ef54ca61

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597623304NDA AUTHORIZED GENERICGreenstone Llc2003-04-08NITROGLYCERINSUBLINGUALTABLET, ORALLY DISINTEGRATINGNDA021134041f127e-5166-4484-bc1a-0a373d1187ae

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950450NitrostatNDARebel Distributors Corp2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA021134dcb552c1-310a-48af-81ad-a74530531dee
2216950810UNAPPROVED DRUG OTHER MARKETING CATEGORYRebel Distributors Corp2005-03-03NITROGLYCERINORALTABLET68462014685b8863e-b8e0-46f4-94a4-7c8e2c66da3f
3493490883NitrostatNDARemedyrepack Inc.2012-03-02, 2013-12-05, 2015-01-02NITROGLYCERINORALTABLET000710418NDA02113418f94362-34c5-4271-9177-d81c92fa2d41, 8d74e592-3ee6-4f05-8b9c-5703de21fe88, fbaddc57-5de4-421d-8590-748768ec87d7
4500900133NitrostatNDAA-S Medication Solutions Llc2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA021134cc481829-0b5a-4e8a-ab5b-cb44d6d2433b
5500900332NitrostatNDAA-S Medication Solutions Llc2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA021134560d7864-96b8-466f-a540-588d40b15298
6521250374NitrostatNDARemedyrepack Inc.2013-05-13NITROGLYCERINSUBLINGUALTABLET000710418NDA02113493b89e13-5af4-4969-90d8-d1bec71291a4
7525840418NitrostatNDAGeneral Injecatables & Vaccines, Inc2010-03-01NITROGLYCERINORALTABLET000710418NDA021134942008d0-dd1a-48cd-8736-80872a04e0e0
8532170066NitrostatNDAAidarex Pharmaceuticals Llc2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA0211343d426e54-489b-4ef7-be06-16762877ce74
9545690461NitrostatNDAA-S Medication Solutions Llc2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA021134479bdd35-8c57-4ff0-9111-fa772861b27a
10545692140NitrostatNDAA-S Medication Solutions Llc2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA021134bcaac33b-ecbf-41fc-9722-37d624438f10
11548680691NitrostatNDAPhysicians Total Care, Inc.1995-08-11NITROGLYCERINORALTABLET000710418NDA021134b32d82ee-7727-4501-a858-a8304135b11b
12548686045NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2009-06-25NITROGLYCERINSUBLINGUALTABLET, ORALLY DISINTEGRATING597623304NDA02113433574801-581a-4028-befd-8e0cc8b6a892
13551542433NitrostatNDACardinal Health2000-05-01NITROGLYCERINSUBLINGUALTABLET000710418NDA021134a60681a9-d659-4c76-a3ce-3f3eea9aff40
14687889089UNAPPROVED DRUG OTHER MARKETING CATEGORYPreferred Pharmaceuticals, Inc.2005-03-03NITROGLYCERINORALTABLET68462014643a04d8f-9dc1-4760-98fc-8f976ddc8a4b
15687889676NitrostatNDAPreferred Pharmaceuticals, Inc.2013-05-15NITROGLYCERINSUBLINGUALTABLET000710418NDA0211348c5eb53a-841e-4ee8-acd1-fb4b33460613

nitroglycerin 0.6 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710419NitrostatNDAParke-Davis Div Of Pfizer Inc2000-05-01NITROGLYCERINSUBLINGUALTABLETNDA02113479ba021e-183c-4b4d-822e-4ff5ef54ca61

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620489NDA AUTHORIZED GENERICGreenstone Llc2003-04-08NITROGLYCERINSUBLINGUALTABLET, ORALLY DISINTEGRATINGNDA021134041f127e-5166-4484-bc1a-0a373d1187ae

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021134NITROSTATPFIZER PHARMACEUTICALS LTD2000-05-01p6500456NDA021134_001, NDA021134_002, NDA021134_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021134_001RXNITROGLYCERIN (0.3MG)SUBLINGUALTABLETFalse2000-05-01NITROSTAT
2NDA021134_002RXNITROGLYCERIN (0.4MG)SUBLINGUALTABLETFalse2000-05-01NITROSTAT
3NDA021134_003RXNITROGLYCERIN (0.6MG)SUBLINGUALTABLETTrue2000-05-01NITROSTAT

patent(s)

#idexpiration dateapplication(s)
1p6500456 (view patent)2018-09-16NDA021134

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1041f127e-5166-4484-bc1a-0a373d1187ae (view SPL)Nitroglycerin Sublingual Tablets, USPprescriptionHuman PrescriptionGreenstone LlcMANUFACTURE2009-09-222597620489, 597623304, 597624921
218f94362-34c5-4271-9177-d81c92fa2d41 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-021493490883
333574801-581a-4028-befd-8e0cc8b6a892 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-09-301548686045
43d426e54-489b-4ef7-be06-16762877ce74 (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-191532170066
543a04d8f-9dc1-4760-98fc-8f976ddc8a4b (view SPL)Nitroglycerin Tablets, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.relabel2009-09-091687889089
6479bdd35-8c57-4ff0-9111-fa772861b27a (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-151545690461
7560d7864-96b8-466f-a540-588d40b15298 (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2015-02-151500900332
879ba021e-183c-4b4d-822e-4ff5ef54ca61 (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-04-218000710417, 000710418, 000710419
985b8863e-b8e0-46f4-94a4-7c8e2c66da3f (view SPL)Nitroglycerin Tablets, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-081216950810
108c5eb53a-841e-4ee8-acd1-fb4b33460613 (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-04-232687889676
118d74e592-3ee6-4f05-8b9c-5703de21fe88 (view SPL)Nitrostat(Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-051493490883
1293b89e13-5af4-4969-90d8-d1bec71291a4 (view SPL)Nitrostat(Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-131521250374
13942008d0-dd1a-48cd-8736-80872a04e0e0 (view SPL)Nitrostat(Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-09-304525840418
14a60681a9-d659-4c76-a3ce-3f3eea9aff40 (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2013-09-192551542433
15b32d82ee-7727-4501-a858-a8304135b11b (view SPL)Nitrostat (Nitroglycerin)0.4 mg USP 25 Tablets BottleprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-01-121548680691, 548681538
16bcaac33b-ecbf-41fc-9722-37d624438f10 (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-061545692140
17cc481829-0b5a-4e8a-ab5b-cb44d6d2433b (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2015-02-151500900133
18dcb552c1-310a-48af-81ad-a74530531dee (view SPL)Nitrostat (Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-161216950450
19fbaddc57-5de4-421d-8590-748768ec87d7 (view SPL)Nitrostat(Nitroglycerin Sublingual Tablets, USP)prescriptionHuman PrescriptionRemedyrepack Inc.2015-01-021493490883

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