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Serving leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Farmers Insurance
Chinese Patent Office

Generated: January 18, 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, Silarx, Teva, Teva Pharms, Wockhardt, Ani Pharms Inc, L Perrigo Co, 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 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 0363-0707-73 2 BLISTER PACK in 1 CARTON (0363-0707-73) > 8 TABLET in 1 BLISTER PACK
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 074512 ANDA Amerisource Bergen 24385-183 24385-183-51 1 BLISTER PACK in 1 CARTON (24385-183-51) > 8 TABLET in 1 BLISTER PACK

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo

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