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 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR MINITRAN 3M 089773 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR MINITRAN 3M 089774 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR MINITRAN 3M 089884 AB2 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITROGLYCERIN HERCON 089885 AB2 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITROGLYCERIN HERCON 089886 AB2 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR NITROGLYCERIN HERCON 020145 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR NITRO-DUR KEY 020145 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITRO-DUR KEY 020145 NITROGLYCERIN Film, Extended Release; Transdermal 0.3MG/HR NITRO-DUR KEY 020145 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITRO-DUR KEY 020145 AB1 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 AB2 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 075076 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.1MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 074609 AB2 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 075073 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.2MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 075075 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 074607 AB2 NITROGLYCERIN Film, Extended Release; Transdermal 0.4MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 074992 AB1 NITROGLYCERIN Film, Extended Release; Transdermal 0.6MG/HR NITROGLYCERIN Mylan TECHNOLOGIES 074559 AB2 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

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