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Covington
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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091496

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NDA 091496 describes NITROGLYCERIN, which is a drug marketed by Hercon Pharm, Lannett Co Inc, Mylan Technologies, Abraxis Pharm, Hospira, Intl Medication, Luitpold, Smith And Nephew, Fougera Pharms Inc, Perrigo Israel, Actavis Labs Fl Inc, Dr Reddys Labs Inc, Glenmark Pharms Sa, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in twenty-five NDAs. It is available from seventeen suppliers. Additional details are available on the NITROGLYCERIN profile page.

The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 091496
Tradename:NITROGLYCERIN
Applicant:Perrigo Israel
Ingredient:nitroglycerin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091496
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 091496
Suppliers and Packaging for NDA: 091496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROGLYCERIN nitroglycerin SPRAY, METERED;SUBLINGUAL 091496 ANDA Perrigo New York Inc 45802-210 N 45802-210-01
NITROGLYCERIN nitroglycerin SPRAY, METERED;SUBLINGUAL 091496 ANDA Perrigo New York Inc 45802-210 N 45802-210-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;SUBLINGUALStrength0.4MG/SPRAY
Approval Date:Sep 20, 2013TE:ABRLD:No

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