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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Federal Trade Commission

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080927

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NDA 080927 describes PROPANTHELINE BROMIDE, which is a drug marketed by Ascot, Heather, Impax Labs, Mylan, Par Pharm, Pvt Form, Sandoz, Tablicaps, Watson Labs, and West-ward Pharms Int, and is included in eleven NDAs. It is available from one supplier. Additional details are available on the PROPANTHELINE BROMIDE profile page.

The generic ingredient in PROPANTHELINE BROMIDE is propantheline bromide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the propantheline bromide profile page.
Summary for 080927
Applicant:West-ward Pharms Int
Ingredient:propantheline bromide
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 080927
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 080927
Suppliers and Packaging for NDA: 080927
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPANTHELINE BROMIDE propantheline bromide TABLET;ORAL 080927 ANDA West-Ward Pharmaceuticals Corp. 0054-4721 N 0054-4721-25

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength7.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
US Army
Harvard Business School
Fish and Richardson
Farmers Insurance

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