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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 073399


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NDA 073399 describes CLEMASTINE FUMARATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heightsrx, Teva Pharms, Wockhardt Bio Ag, Ani Pharms, L Perrigo Co, Omnivium Pharms, Pld Acquisitions Llc, and Teva, and is included in eleven NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 073399
Tradename:CLEMASTINE FUMARATE
Applicant:Genus
Ingredient:clemastine fumarate
Patents:0
Medical Subject Heading (MeSH) Categories for 073399
Suppliers and Packaging for NDA: 073399
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 073399 ANDA Ayurax, LLC 73308-358 73308-358-12 120 mL in 1 BOTTLE, PLASTIC (73308-358-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 0.5MG BASE/5ML
Approval Date:Jun 30, 1994TE:AARLD:No

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