Suppliers and packagers for generic ingredient: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acella	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	203375	ANDA	Acella Pharmaceuticals, LLC	42192-607-04	118 mL in 1 BOTTLE, PLASTIC (42192-607-04)	2016-09-21
Acella	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	203375	ANDA	Acella Pharmaceuticals, LLC	42192-607-16	473 mL in 1 BOTTLE, PLASTIC (42192-607-16)	2016-09-21
Acella	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	203375	ANDA	Acella Pharmaceuticals, LLC	42192-607-40	40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)	2016-09-21
Acella	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	203375	ANDA	Acella Pharmaceuticals, LLC	42192-630-04	118 mL in 1 BOTTLE, PLASTIC (42192-630-04)	2025-02-01
Wockhardt Bio Ag	BROMFED-DM	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	088811	ANDA	Proficient Rx LP	63187-400-04	118 mL in 1 BOTTLE, PLASTIC (63187-400-04)	2010-06-15