ZENATANE - 55111-135-81 - (ISOTRETINOIN)

Alphabetical Index


Drug Information of ZENATANE

Product NDC: 55111-135
Proprietary Name: ZENATANE
Non Proprietary Name: ISOTRETINOIN
Active Ingredient(s): 10    mg/1 & nbsp;   ISOTRETINOIN
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, GELATIN COATED
Coding System: National Drug Codes(NDC)

Labeler Information of ZENATANE

Product NDC: 55111-135
Labeler Name: Dr. Reddy's Laboratories Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA202099
Marketing Category: ANDA
Start Marketing Date: 20130326

Package Information of ZENATANE

Package NDC: 55111-135-81
Package Description: 3 BLISTER PACK in 1 CARTON (55111-135-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-135-79)

NDC Information of ZENATANE

NDC Code 55111-135-81
Proprietary Name ZENATANE
Package Description 3 BLISTER PACK in 1 CARTON (55111-135-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-135-79)
Product NDC 55111-135
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ISOTRETINOIN
Dosage Form Name CAPSULE, GELATIN COATED
Route Name ORAL
Start Marketing Date 20130326
Marketing Category Name ANDA
Labeler Name Dr. Reddy's Laboratories Limited
Substance Name ISOTRETINOIN
Strength Number 10
Strength Unit mg/1
Pharmaceutical Classes Retinoid [EPC],Retinoids [Chemical/Ingredient]

Complete Information of ZENATANE


General Information