Details for New Drug Application (NDA): 072034

NDA 072034 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, Viwit Pharm, and Baxter Hlthcare, and is included in thirty-two 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-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 072034

Tradename:	NITROGLYCERIN
Applicant:	Am Regent
Ingredient:	nitroglycerin
Patents:	0

Pharmacology for NDA: 072034

Physiological Effect

Vasodilation

Medical Subject Heading (MeSH) Categories for 072034

Explosive Agents

Vasodilator Agents

Suppliers and Packaging for NDA: 072034

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROGLYCERIN	nitroglycerin	INJECTABLE;INJECTION	072034	ANDA	Henry Schein, Inc.	0404-9928	0404-9928-10	1 VIAL in 1 BAG (0404-9928-10) / 10 mL in 1 VIAL
NITROGLYCERIN	nitroglycerin	INJECTABLE;INJECTION	072034	ANDA	American Regent, Inc.	0517-4810	0517-4810-25	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML
Approval Date:	May 24, 1988	TE:		RLD:	No

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