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Last Updated: September 28, 2021

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Details for New Drug Application (NDA): 021780

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NDA 021780 describes NITROMIST, which is a drug marketed by Evus and is included in one NDA. It is available from one supplier. 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. Thirty suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 021780

Tradename:	NITROMIST
Applicant:	Evus
Ingredient:	nitroglycerin
Patents:	0
Formulation / Manufacturing:	see details

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
Evus	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006	⤷ Free Forever Trial	⤷ Free Forever Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.