Application 012015

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COGENTIN	BENZTROPINE MESYLATE	INJECTABLE;INJECTION	1MG/ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-012	Benztropine Mesylate	Benztropine Mesylate	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-012	Benztropine Mesylate	Benztropine Mesylate	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-012	Benztropine Mesylate	Benztropine Mesylate	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-012	Benztropine Mesylate	Benztropine Mesylate	Akorn	NDA AUTHORIZED GENERIC	Current
64725-0012	Benztropine Mesylate	Benztropine Mesylate	TYA Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
76478-611	Cogentin	benztropine mesylate	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-611	Cogentin	benztropine mesylate	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-611	Cogentin	benztropine mesylate	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current