AVANTHI INC Application 078648

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	6MG;120MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-005	Dexbrompherniramine Maleate and Pseudoephedrine Sulfate	Dexbrompherniramine Maleate and Pseudoephedrine Sulfate	KVK-TECH, INC.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
39563	ORIG	2014-01-14
31380	ORIG	2013-03-01