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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Harvard Business School

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074512

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NDA 074512 describes CLEMASTINE FUMARATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Lannett Co Inc, 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. Twelve suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 074512
Applicant:L Perrigo Co
Ingredient:clemastine fumarate
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074512
Suppliers and Packaging for NDA: 074512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 074512 ANDA Walgreen Company 0363-0707 N 0363-0707-73
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 074512 ANDA Amerisource Bergen 24385-183 N 24385-183-51

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.34MG
Approval Date:Nov 22, 1995TE:RLD:No

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US Army
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