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Serving leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Citi
Julphar
Novartis
Covington
Fish and Richardson
Boehringer Ingelheim
Fuji
Merck

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202489

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NDA 202489 describes TINIDAZOLE, which is a drug marketed by Edenbridge Pharms, Novel Labs Inc, Unique Pharm Labs, and West-ward Pharms Int, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the TINIDAZOLE profile page.

The generic ingredient in TINIDAZOLE is tinidazole. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
Summary for 202489
Tradename:TINIDAZOLE
Applicant:Unique Pharm Labs
Ingredient:tinidazole
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 202489
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 202489
Suppliers and Packaging for NDA: 202489
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TINIDAZOLE tinidazole TABLET;ORAL 202489 ANDA Pack Pharmaceuticals, LLC 16571-214 16571-214-04 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-214-04)
TINIDAZOLE tinidazole TABLET;ORAL 202489 ANDA Pack Pharmaceuticals, LLC 16571-215 16571-215-22 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 9, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 9, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Teva
Harvard Business School
Merck
UBS
Argus Health
QuintilesIMS
Queensland Health
US Department of Justice

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