GLENMARK GENERICS Application 202145

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	CREAM;TOPICAL	0.1%	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-464	Hydrocortisone Butyrate	Hydrocortisone Butyrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
19070	ORIG	2013-10-02
9973	ORIG	2013-10-01