Details for New Drug Application (NDA): 091496

NDA 091496 describes NITROGLYCERIN, which is a drug marketed by Lannett Co Inc, Mylan Technologies, Zydus Pharms, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in thirty-one NDAs. It is available from twenty-four 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-three suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 091496

Tradename:	NITROGLYCERIN
Applicant:	Padagis Israel
Ingredient:	nitroglycerin
Patents:	0

Pharmacology for NDA: 091496

Physiological Effect

Vasodilation

Medical Subject Heading (MeSH) Categories for 091496

Explosive Agents

Vasodilator Agents

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	Padagis Israel Pharmaceuticals Ltd	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	Padagis Israel Pharmaceuticals Ltd	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:	RX	Dosage:	SPRAY, METERED;SUBLINGUAL			Strength	0.4MG/SPRAY
Approval Date:	Sep 20, 2013	TE:	AB	RLD:	No

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