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AstraZeneca
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US Department of Justice
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200602

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NDA 200602 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 200602

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

Pharmacology for NDA: 200602

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 200602

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET;ORAL 200602 ANDA PD-Rx Pharmaceuticals, Inc. 43063-740 43063-740-01 100 TABLET in 1 BOTTLE, PLASTIC (43063-740-01)
METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET;ORAL 200602 ANDA PD-Rx Pharmaceuticals, Inc. 43063-741 43063-741-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-741-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 24, 2012TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 24, 2012TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Covington
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