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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073283

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NDA 073283 describes CLEMASTINE FUMARATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Silarx, Teva, Teva Pharms, Wockhardt, Ani Pharms Inc, L Perrigo Co, Pld Acquisitions Llc, and Sandoz, and is included in eleven NDAs. It is available from twelve suppliers. Additional details are available on the CLEMASTINE FUMARATE profile page.

The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 073283
Ingredient:clemastine fumarate
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 073283
Suppliers and Packaging for NDA: 073283
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073283 ANDA Teva Pharmaceuticals USA Inc 0093-0308 N 0093-0308-01
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073283 ANDA Northwind Pharmaceuticals, LLC 51655-425 N 51655-425-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.68MG
Approval Date:Jan 31, 1992TE:RLD:No

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