Application 088811

Type: ANDA
Sponsor: WOCKHARDT BIO AG

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60432-275	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60432-837	Bromfed DM	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60432-837	Bromfed DM	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
63187-400	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Proficient Rx LP	ANDA	Current
63187-400	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Proficient Rx LP	ANDA	Current
68788-7554	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7554	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7554	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7554	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7861	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7861	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Preferred Pharmaceuticals Inc.	ANDA	Current