Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 three 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. Thirty-five 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
Pharmacology for NDA: 021780
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 021780
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:RXDosage:AEROSOL, METERED;SUBLINGUALStrength0.4MG/SPRAY
Approval Date:Nov 2, 2006TE:RLD:Yes

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