SANDOZ Application 008678

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ISONIAZID	ISONIAZID	TABLET;ORAL	100MG	Yes	No
003	ISONIAZID	ISONIAZID	TABLET;ORAL	300MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-4350	Isoniazid	Isoniazid	Eon Labs, Inc.	NDA	Current
0185-4351	Isoniazid	Isoniazid	Eon Labs, Inc.	NDA	Current
43063-709	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-710	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68788-8927	Isoniazid	Isoniazid	Preferred Pharmaceuticals Inc.	NDA	Current