Claravis - 54868-6308-0 - (isotretinoin)

Alphabetical Index


Drug Information of Claravis

Product NDC: 54868-6308
Proprietary Name: Claravis
Non Proprietary Name: isotretinoin
Active Ingredient(s): 40    mg/1 & nbsp;   isotretinoin
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Claravis

Product NDC: 54868-6308
Labeler Name: Physicians Total Care, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076135
Marketing Category: ANDA
Start Marketing Date: 20110920

Package Information of Claravis

Package NDC: 54868-6308-0
Package Description: 3 BLISTER PACK in 1 CARTON (54868-6308-0) > 10 CAPSULE in 1 BLISTER PACK

NDC Information of Claravis

NDC Code 54868-6308-0
Proprietary Name Claravis
Package Description 3 BLISTER PACK in 1 CARTON (54868-6308-0) > 10 CAPSULE in 1 BLISTER PACK
Product NDC 54868-6308
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name isotretinoin
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20110920
Marketing Category Name ANDA
Labeler Name Physicians Total Care, Inc.
Substance Name ISOTRETINOIN
Strength Number 40
Strength Unit mg/1
Pharmaceutical Classes Retinoid [EPC],Retinoids [Chemical/Ingredient]

Complete Information of Claravis


General Information