Application 075945

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMNESTEEM	ISOTRETINOIN	CAPSULE;ORAL	10MG	No	No
002	AMNESTEEM	ISOTRETINOIN	CAPSULE;ORAL	20MG	No	No
003	AMNESTEEM	ISOTRETINOIN	CAPSULE;ORAL	40MG	No	No
004	AMNESTEEM	ISOTRETINOIN	CAPSULE;ORAL	30MG	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6611	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6612	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6614	Amnesteem	isotretinoin	Mylan Pharmaceuticals Inc.	ANDA	Current