Details for New Drug Application (NDA): 021780

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NDA 021780 describes NITROMIST, which is a drug marketed by Mist Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the NITROMIST profile page.

The generic ingredient in NITROMIST is nitroglycerin. There are thirty-six drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 021780

Tradename:	NITROMIST
Applicant:	Mist Pharms Llc
Ingredient:	nitroglycerin
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021780

Ingredient-type	Nitrates
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 021780

Explosive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 021780

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780	NDA AUTHORIZED GENERIC	Rouses Point Pharm	43478-410	43478-410-03	1 BOTTLE in 1 CARTON (43478-410-03) > 60 AEROSOL, METERED in 1 BOTTLE
NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780	NDA AUTHORIZED GENERIC	Rouses Point Pharm	43478-410	43478-410-07	1 BOTTLE in 1 CARTON (43478-410-07) > 200 AEROSOL, METERED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;SUBLINGUAL			Strength	0.4MG/SPRAY
Approval Date:	Nov 2, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021780

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mist Pharms Llc	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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