Application 203997

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	SYRUP;ORAL	2MG/5ML;10MG/5ML;30MG/5ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-847	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-847	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63629-2058	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	ANDA	Current
63629-2058	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	ANDA	Current
63629-2058	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	ANDA	Current
63629-2059	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	ANDA	Current
63629-2059	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	ANDA	Current
63629-2059	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	ANDA	Current