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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073283

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NDA 073283 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 073283

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 073283

Suppliers and Packaging for NDA: 073283

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073283 ANDA Teva Pharmaceuticals USA Inc 0093-0308 0093-0308-01 100 TABLET in 1 BOTTLE (0093-0308-01)
CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073283 ANDA Northwind Pharmaceuticals, LLC 51655-425 51655-425-04 4 TABLET in 1 BOTTLE, DISPENSING (51655-425-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.68MG
Approval Date:Jan 31, 1992TE:RLD:No


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