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Generated: November 17, 2018

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Details for New Drug Application (NDA): 089774

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NDA 089774 describes MINITRAN, which is a drug marketed by Medicis, Valeant Pharms, and Valeant Pharms North, and is included in four NDAs. It is available from three suppliers. Additional details are available on the MINITRAN profile page.

The generic ingredient in MINITRAN 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 089774
Tradename:MINITRAN
Applicant:Valeant Pharms
Ingredient:nitroglycerin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089774
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 089774
Suppliers and Packaging for NDA: 089774
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089774 ANDA Graceway Pharmaceuticals, LLC 29336-304 29336-304-02 30 PATCH in 1 CARTON (29336-304-02) > 1 d in 1 PATCH
MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089774 ANDA Graceway Pharmaceuticals, LLC 29336-324 29336-324-30 30 PATCH in 1 CARTON (29336-324-30) > 1 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.6MG/HR
Approval Date:Aug 30, 1996TE:AB1RLD:No

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