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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Fish and Richardson
Queensland Health
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Federal Trade Commission

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040642

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NDA 040642 describes METHSCOPOLAMINE BROMIDE, which is a drug marketed by Bayshore Pharms Llc, Vintage Pharms, Breckenridge Pharm, and Pvt Form, and is included in four NDAs. It is available from five suppliers. Additional details are available on the METHSCOPOLAMINE BROMIDE profile page.

The generic ingredient in METHSCOPOLAMINE BROMIDE is methscopolamine bromide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the methscopolamine bromide profile page.

Summary for NDA: 040642

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040642

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 040642

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methscopolamine bromide
TABLET;ORAL 040642 ANDA Breckenridge Pharmaceutical, Inc. 51991-191 51991-191-01 100 TABLET in 1 BOTTLE (51991-191-01)
methscopolamine bromide
TABLET;ORAL 040642 ANDA Breckenridge Pharmaceutical, Inc. 51991-192 51991-192-06 60 TABLET in 1 BOTTLE (51991-192-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 6, 2011TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 6, 2011TE:AARLD:No

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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
Johnson and Johnson
Daiichi Sankyo
Queensland Health
Argus Health

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