Application 203375

Type: ANDA
Sponsor: ACELLA

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
42192-607	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Acella Pharmaceuticals, LLC	ANDA	Current
42192-607	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Acella Pharmaceuticals, LLC	ANDA	Current
42192-607	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Acella Pharmaceuticals, LLC	ANDA	Current
42192-607	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Acella Pharmaceuticals, LLC	ANDA	Current
63187-930	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Proficient Rx LP	ANDA	Current
63187-930	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Proficient Rx LP	ANDA	Current
63187-930	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Proficient Rx LP	ANDA	Current
63187-930	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Proficient Rx LP	ANDA	Current
68025-002	Bromfed DM	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Vertical Pharmaceuticals, LLC	ANDA	Current
68788-7123	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7123	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7123	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7123	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7123	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7975	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7975	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current