| 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) |
| 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 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 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] |