Application 080028

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BLEPH-10	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	10%	No	Yes
002	BLEPH-30	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	30%	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11980-011	BLEPH-10	sulfacetamide sodium	Allergan, Inc.	ANDA	Current
11980-011	BLEPH-10	sulfacetamide sodium	Allergan, Inc.	ANDA	Current
60758-018	sulfacetamide	sulfacetamide sodium	Pacific Pharma, Inc.	ANDA	Current