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Details for New Drug Application (NDA): 088811

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NDA 088811 describes BROMFED-DM, which is a drug marketed by Wockhardt and is included in two NDAs. It is available from three suppliers. Additional details are available on the BROMFED-DM profile page.

The generic ingredient in BROMFED-DM is brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride profile page.

Summary for NDA: 088811

Suppliers and Packaging for NDA: 088811

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMFED-DM
brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride
SYRUP;ORAL 088811 ANDA Physicians Total Care, Inc. 54868-6377 54868-6377-0 118 mL in 1 BOTTLE, PLASTIC (54868-6377-0)
BROMFED-DM
brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride
SYRUP;ORAL 088811 ANDA Morton Grove Pharmaceuticals, Inc. 60432-275 60432-275-04 118 mL in 1 BOTTLE, PLASTIC (60432-275-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML;10MG/5ML;30MG/5ML
Approval Date:Jun 7, 1985TE:AARLD:Yes


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