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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216452

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NDA 216452 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, Encube, Tp Anda Holdings, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon Research, Sigmapharm Labs Llc, Viwit Pharm, and Baxter Hlthcare, and is included in thirty-five NDAs. It is available from twenty-eight 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-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 216452

Tradename:	NITROGLYCERIN
Applicant:	Encube
Ingredient:	nitroglycerin
Patents:	0

Pharmacology for NDA: 216452

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 216452

Explosive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 216452

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROGLYCERIN	nitroglycerin	OINTMENT;INTRA-ANAL	216452	ANDA	Encube Ethicals, Inc.	21922-048	21922-048-05	1 TUBE in 1 CARTON (21922-048-05) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;INTRA-ANAL			Strength	0.4%
Approval Date:	Dec 16, 2024	TE:	AB	RLD:	No

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