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Last Updated: January 25, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205292

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NDA 205292 describes BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Acella, Mayne Pharma Inc, Paddock Llc, Taro, and Vintage Pharms, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride profile page.
Suppliers and Packaging for NDA: 205292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 205292 ANDA Paddock Laboratories, LLC 0574-1104 0574-1104-04 118 mL in 1 BOTTLE, PLASTIC (0574-1104-04)
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 205292 ANDA Paddock Laboratories, LLC 0574-1104 0574-1104-16 473 mL in 1 BOTTLE, PLASTIC (0574-1104-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML;10MG/5ML;30MG/5ML
Approval Date:Jul 15, 2014TE:AARLD:No

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