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Generated: December 18, 2018

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Details for New Drug Application (NDA): 089885

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NDA 089885 describes NITROGLYCERIN, which is a drug marketed by Hercon Pharm, Lannett Co Inc, Mylan Technologies, Abraxis Pharm, Hospira, Intl Medication, Luitpold, Smith And Nephew, Fougera Pharms Inc, Perrigo Israel, Actavis Labs Fl Inc, Dr Reddys Labs Inc, Glenmark Pharms Sa, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in twenty-five NDAs. It is available from nineteen 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. Forty suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 089885
Tradename:NITROGLYCERIN
Applicant:Hercon Pharm
Ingredient:nitroglycerin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089885
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 089885
Suppliers and Packaging for NDA: 089885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089885 ANDA Major Pharmaceuticals 0904-5496 0904-5496-46 30 POUCH in 1 CARTON (0904-5496-46) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH
NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089885 ANDA Hercon Laboratories Corporation 49730-112 49730-112-30 30 POUCH in 1 BOX (49730-112-30) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.4MG/HR
Approval Date:Oct 30, 1998TE:AB2RLD:No

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