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Generated: April 23, 2017

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Clemastine fumarate - Generic Drug Details

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What are the generic drug sources for clemastine fumarate and what is the scope of freedom to operate?

Clemastine fumarate
is the generic ingredient in three branded drugs marketed by Apotex Inc, Perrigo, Novartis, Sandoz, Wockhardt, Actavis Mid Atlantic, Ani Pharms Inc, Teva, Silarx, and Teva Pharms, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for clemastine fumarate. Seventeen suppliers are listed for this compound.

Summary for Generic Name: clemastine fumarate

Drug Master File Entries: see list2
Suppliers / Packagers: see list17
Bulk Api Vendors: see list54
Clinical Trials: see list230
Patent Applications: see list5,385
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:clemastine fumarate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
clemastine fumarate
SYRUP;ORAL074863-001Mar 13, 1998AARXNoNo► Subscribe► Subscribe
clemastine fumarate
TABLET;ORAL073283-001Jan 31, 1992RXNoYes► Subscribe► Subscribe
Apotex Inc
clemastine fumarate
SYRUP;ORAL075703-001Nov 27, 2000DISCNNoNo► Subscribe► Subscribe
clemastine fumarate
TABLET;ORAL073459-001Oct 31, 1993DISCNNoNo► Subscribe► Subscribe
clemastine fumarate
SYRUP;ORAL018675-001Jun 28, 1985DISCNYesNo► Subscribe► Subscribe
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