Application 076135

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARAVIS	ISOTRETINOIN	CAPSULE;ORAL	40MG	No	Yes
002	CLARAVIS	ISOTRETINOIN	CAPSULE;ORAL	20MG	No	No
003	CLARAVIS	ISOTRETINOIN	CAPSULE;ORAL	30MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1055	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1056	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-1057	Claravis	Isotretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
24052	ORIG	2015-07-02
44289	ORIG	2005-07-28