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Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075703

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NDA 075703 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 075703
Applicant:Apotex Inc
Ingredient:clemastine fumarate
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075703

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrengthEQ 0.5MG BASE/5ML
Approval Date:Nov 27, 2000TE:RLD:No

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Federal Trade Commission
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