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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076387

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NDA 076387 describes CLOTRIMAZOLE, which is a drug marketed by Teva, Glenmark Pharms, Fougera Pharms, Taro, Paddock Llc, Actavis Mid Atlantic, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for NDA: 076387

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 076387


Suppliers and Packaging for NDA: 076387

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TROCHE/LOZENGE;ORAL 076387 ANDA West-Ward Pharmaceuticals Corp. 0054-4146 0054-4146-22 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)
TROCHE/LOZENGE;ORAL 076387 ANDA West-Ward Pharmaceuticals Corp. 0054-4146 0054-4146-23 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;ORALStrength10MG
Approval Date:Jul 29, 2004TE:ABRLD:No

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