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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo

Generated: June 18, 2018

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, Breckenridge Pharm, Pvt Form, and Vintage Pharms, 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 040642
Applicant:Breckenridge Pharm
Ingredient:methscopolamine bromide
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 methscopolamine bromide TABLET;ORAL 040642 ANDA Breckenridge Pharmaceutical, Inc. 51991-191 N 51991-191-01
METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET;ORAL 040642 ANDA Breckenridge Pharmaceutical, Inc. 51991-192 N 51991-192-06

Profile for product number 001

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

Profile for product number 002

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

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