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 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087355

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NDA 087355 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, Alvogen, Dr Reddys, Glenmark Pharms Sa, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in twenty-six NDAs. It is available from seventeen 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. Thirty-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 087355
Tradename:NITROGLYCERIN
Applicant:Fougera Pharms Inc
Ingredient:nitroglycerin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087355
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 087355
Suppliers and Packaging for NDA: 087355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROGLYCERIN nitroglycerin OINTMENT;TRANSDERMAL 087355 ANDA Savage Laboratories a division of Fougera Pharmaceuticals Inc. 0281-0326 0281-0326-08 48 PACKET in 1 BOX (0281-0326-08) > 1 g in 1 PACKET
NITROGLYCERIN nitroglycerin OINTMENT;TRANSDERMAL 087355 ANDA Savage Laboratories a division of Fougera Pharmaceuticals Inc. 0281-0326 0281-0326-30 30 g in 1 TUBE (0281-0326-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TRANSDERMALStrength2%
Approval Date:Jul 8, 1988TE:RLD:No

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