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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 218756

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NDA 218756 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, Solaris Pharma Corp, 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-six NDAs. It is available from twenty-nine 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 218756

Tradename:	NITROGLYCERIN
Applicant:	Solaris Pharma Corp
Ingredient:	nitroglycerin
Patents:	0

Pharmacology for NDA: 218756

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 218756

Explosive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 218756

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROGLYCERIN	nitroglycerin	OINTMENT;INTRA-ANAL	218756	ANDA	Solaris Pharma Corporation	73473-500	73473-500-30	30 g in 1 TUBE (73473-500-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;INTRA-ANAL			Strength	0.4%
Approval Date:	Dec 18, 2025	TE:	AB	RLD:	No

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