Amnesteem - 54868-5039-0 - (isotretinoin)

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Drug Information of Amnesteem

Product NDC: 54868-5039
Proprietary Name: Amnesteem
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 Amnesteem

Product NDC: 54868-5039
Labeler Name: Physicians Total Care, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA075945
Marketing Category: ANDA
Start Marketing Date: 20101102

Package Information of Amnesteem

Package NDC: 54868-5039-0
Package Description: 3 BLISTER PACK in 1 CARTON (54868-5039-0) > 10 CAPSULE in 1 BLISTER PACK

NDC Information of Amnesteem

NDC Code 54868-5039-0
Proprietary Name Amnesteem
Package Description 3 BLISTER PACK in 1 CARTON (54868-5039-0) > 10 CAPSULE in 1 BLISTER PACK
Product NDC 54868-5039
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name isotretinoin
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20101102
Marketing Category Name ANDA
Labeler Name Physicians Total Care, Inc.
Substance Name ISOTRETINOIN
Strength Number 10
Strength Unit mg/1
Pharmaceutical Classes Retinoid [EPC],Retinoids [Chemical/Ingredient]

Complete Information of Amnesteem


General Information