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Novartis
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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203808

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NDA 203808 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. Ten suppliers are listed for this compound. Additional details are available on the tinidazole profile page.

Summary for 203808

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 203808

Ingredient-typeNitroimidazoles

Medical Subject Heading (MeSH) Categories for 203808

Suppliers and Packaging for NDA: 203808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TINIDAZOLE tinidazole TABLET;ORAL 203808 ANDA Edenbridge Pharmaceuticals, LLC 42799-207 42799-207-01 40 TABLET in 1 BOTTLE (42799-207-01)
TINIDAZOLE tinidazole TABLET;ORAL 203808 ANDA Edenbridge Pharmaceuticals, LLC 42799-208 42799-208-01 20 TABLET in 1 BOTTLE (42799-208-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 4, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 4, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Novartis
Johnson and Johnson
AstraZeneca
Argus Health
Cipla
Queensland Health
US Army
Harvard Business School
Fuji

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