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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Julphar
Baxter
Accenture
Federal Trade Commission
Queensland Health
Harvard Business School
Cipla
Merck

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202044

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NDA 202044 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 six 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. Eight suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
Summary for 202044
Tradename:TINIDAZOLE
Applicant:Novel Labs Inc
Ingredient:tinidazole
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 202044
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 202044
Suppliers and Packaging for NDA: 202044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TINIDAZOLE tinidazole TABLET;ORAL 202044 ANDA Novel Laboratories, Inc. 40032-550 N 40032-550-08
TINIDAZOLE tinidazole TABLET;ORAL 202044 ANDA Novel Laboratories, Inc. 40032-550 N 40032-550-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 30, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 30, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
Mallinckrodt
Dow
Queensland Health
Accenture
Colorcon
Daiichi Sankyo
Merck

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