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Generated: July 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207676

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NDA 207676 describes BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Acella, Mayne Pharma Inc, Paddock Llc, Taro Pharm, 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. Eight 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: 207676
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 207676 ANDA Mayne Pharma 51862-535 51862-535-04 118 mL in 1 BOTTLE, PLASTIC (51862-535-04)
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 207676 ANDA Mayne Pharma 51862-535 51862-535-16 473 mL in 1 BOTTLE, PLASTIC (51862-535-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML;10MG/5ML;30MG/5ML
Approval Date:Dec 4, 2018TE:AARLD:No

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