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NITROGLYCERIN

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Nitro-Dur (nitroglycerin) Transdermal Infusion System, 0.1 mg/hr, 0.2 mg/ hr, 0.3 mg/hr, 0.4 mg/hr, 0.6 mg/hr and 0.8 mg/ hr., Schering NDA 20-145 / S-016 10/18/02 10/28/02 | Nitroglycerin Transdermal System, 0.6 mg/hr. Mylan Technologies, ANDA 74-992 11/12/99 7/11/01 Nitroglycerin Transdermal System, 0.1 mg/hr. Mylan ANDA 75-033 2/6/98 3/19/99 Nitroglycerin Transdermal Systems, Mylan Technologies, ANDA 75-073, 75-075, & 75-076 11/12/99 7/11/01 Nitroglycerin Transdermal Systems, 0.2 mg/hr, Hercon ANDA 89-884 10/30/98 11/2/98 8/4/03 Nitroglycerin Transdermal Systems, 0.4 mg/hr, Hercon ANDA 89-885 10/30/98 11/2/98 8/4/03 Nitroglycerin Transdermal Systems, 0.6 mg/hr, Hercon ANDA 89-886 10/30/98 11/2/98 8/4/03 Nitrolingual Pumpspray (nitroglycerin lingual spray), 400 mcg per spray. G. Pohl Boskamp GmbH & Co. NDA 18-705/S-012 11/5/02 11/19/02 | Nitrostat (nitroglycerin sublingual Tablets, 0.3, 0.4, & 0.6 mg, Parke-Davis NDA 21-134 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR MINITRAN 3M | 089772 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR MINITRAN 3M | 089773 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR MINITRAN 3M | 089774 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR MINITRAN 3M | 089884 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITROGLYCERIN HERCON 089885 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITROGLYCERIN HERCON 089886 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR NITROGLYCERIN HERCON 020145 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR NITRO-DUR KEY 020145 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITRO-DUR KEY 020145 NITROGLYCERIN Film, Extended Release; Transdermal 0.3MG/HR NITRO-DUR KEY 020145 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITRO-DUR KEY 020145 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR NITRO-DUR KEY 020145 BX NITROGLYCERIN Film, Extended Release; Transdermal 0.8MG/HR NITRO-DUR KEY 075033 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 075076 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 074609 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 075073 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 075075 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 074607 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 074992 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 074559 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR NITROGLYCERIN Mylan TECHNOLOGIES | 074083 NITROGLYCERIN Injection 0.1MG/ML NITROGLYCERIN IN DEXTROSE 5% Abbott | 071846 NITROGLYCERIN Injection 10MG/100ML NITROGLYCERIN IN DEXTROSE 5% Abbott | 071847 NITROGLYCERIN Injection 20MG/100ML NITROGLYCERIN IN DEXTROSE 5% Abbott | 071848 NITROGLYCERIN Injection 40MG/100ML NITROGLYCERIN IN DEXTROSE 5% Abbott | 018531 NITROGLYCERIN Injection 5MG/ML NITROGLYCERIN Abbott | 018621 NITROGLYCERIN Injection 5MG/ML NITRO-BID AVENTIS 019970 NITROGLYCERIN Injection 10MG/100ML NITROGLYCERIN IN DEXTROSE 5% Baxter | 019970 NITROGLYCERIN Injection 20MG/100ML NITROGLYCERIN IN DEXTROSE 5% Baxter | 019970 NITROGLYCERIN Injection 40MG/100ML NITROGLYCERIN IN DEXTROSE 5% Baxter | 072034 NITROGLYCERIN Injection 5MG/ML NITROGLYCERIN LUITPOLD | 087355 NITROGLYCERIN Ointment; Transdermal 2% NITROGLYCERIN FOUGERA | 018705 NITROGLYCERIN Spray, Metered; Sublingual 0.4MG/SPRAY NITROLINGUAL PUMPSPRAY POHL BOSKAMP | 021134 NITROGLYCERIN Tablet; Sublingual 0.3MG NITROSTAT PFIZER 021134 NITROGLYCERIN Tablet; Sublingual 0.4MG NITROSTAT PFIZER 021134 NITROGLYCERIN Tablet; Sublingual 0.6MG NITROSTAT PFIZER NITRO-DUR (nitroglycerin) Transdermal Infusion System, Schering Corporation Nitroglycerin Transdermal System, Schwarz Pharma, Approval Nitrolingual Pumpspray (nitroglycerin lingual spray), First Horizon Pharma, Labeling Revision | NITRO-DUR (nitroglycerin) Transdermal Infusion System, Schering Corporation, Labeling Revision | NitroMist (Nitroglycerin) Lingual Aerosol, NovaDel Pharma, Approval | Nitrolingual (nitroglycerin) Spray, Sciele Pharma, Inc., Package Change | NitroMist (nitroglycerin) Lingual Spray, Akrimax Pharmaceuticals, LLC, Labeling Revision | Rectiv (nitroglycerin) Ointment, ProStrakan, Inc., Approval | Nitrostat (nitroglycerin) Sublingual Tablets, Pfizer, Inc., Labeling Revision | Nitroglycerin In Dextrose 5%, nitroglycerin, Injectable; Injection, Baxter Hlthcare, Manufacturing Change or Addition

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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