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Generated: April 30, 2017

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Details for New Drug Application (NDA): 073458

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NDA 073458 describes CLEMASTINE FUMARATE, which is a drug marketed by Apotex Inc, Perrigo, Sandoz, Wockhardt, Actavis Mid Atlantic, Ani Pharms Inc, Teva, Silarx, and Teva Pharms, and is included in eleven NDAs. It is available from sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.

Summary for NDA: 073458

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 073458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clemastine fumarate
TABLET;ORAL 073458 ANDA Physicians Total Care, Inc. 54868-5913 54868-5913-0 100 TABLET in 1 BOTTLE (54868-5913-0)
clemastine fumarate
TABLET;ORAL 073458 ANDA Carilion Materials Management 68151-2456 68151-2456-0 1 TABLET in 1 PACKAGE (68151-2456-0)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.34MG
Approval Date:Oct 31, 1993TE:RLD:No

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