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Last Updated: September 25, 2021

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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, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Fougera Pharms Inc, Perrigo Israel, Actavis Labs Fl Inc, Alvogen, Dr Reddys, Glenmark Pharms Sa, Rubicon, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in twenty-seven NDAs. It is available from sixteen 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 suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 091496
Applicant:Perrigo Israel
Formulation / Manufacturing:see details
Pharmacology for NDA: 091496
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 45802-210-01 1 BOTTLE in 1 CARTON (45802-210-01) > 60 SPRAY in 1 BOTTLE
NITROGLYCERIN nitroglycerin SPRAY, METERED;SUBLINGUAL 091496 ANDA Perrigo New York Inc 45802-210 45802-210-02 1 BOTTLE in 1 CARTON (45802-210-02) > 200 SPRAY in 1 BOTTLE

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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