Claravis - 0555-1054-86 - (isotretinoin)

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Drug Information of Claravis

Product NDC: 0555-1054
Proprietary Name: Claravis
Non Proprietary Name: isotretinoin
Active Ingredient(s): 10    mg/1 & nbsp;   isotretinoin
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Claravis

Product NDC: 0555-1054
Labeler Name: Barr Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076356
Marketing Category: ANDA
Start Marketing Date: 20030509

Package Information of Claravis

Package NDC: 0555-1054-86
Package Description: 3 BLISTER PACK in 1 CARTON (0555-1054-86) > 10 CAPSULE in 1 BLISTER PACK

NDC Information of Claravis

NDC Code 0555-1054-86
Proprietary Name Claravis
Package Description 3 BLISTER PACK in 1 CARTON (0555-1054-86) > 10 CAPSULE in 1 BLISTER PACK
Product NDC 0555-1054
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name isotretinoin
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20030509
Marketing Category Name ANDA
Labeler Name Barr Laboratories, Inc.
Substance Name ISOTRETINOIN
Strength Number 10
Strength Unit mg/1
Pharmaceutical Classes Retinoid [EPC],Retinoids [Chemical/Ingredient]

Complete Information of Claravis


General Information