| Product NDC: | 61748-301 |
| Proprietary Name: | Myorisan |
| Non Proprietary Name: | isotretinoin |
| Active Ingredient(s): | 10 mg/1 & nbsp; isotretinoin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, LIQUID FILLED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 61748-301 |
| Labeler Name: | VersaPharm Incorporated |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076485 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120501 |
| Package NDC: | 61748-301-13 |
| Package Description: | 3 BLISTER PACK in 1 CARTON (61748-301-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| NDC Code | 61748-301-13 |
| Proprietary Name | Myorisan |
| Package Description | 3 BLISTER PACK in 1 CARTON (61748-301-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Product NDC | 61748-301 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | isotretinoin |
| Dosage Form Name | CAPSULE, LIQUID FILLED |
| Route Name | ORAL |
| Start Marketing Date | 20120501 |
| Marketing Category Name | ANDA |
| Labeler Name | VersaPharm Incorporated |
| Substance Name | ISOTRETINOIN |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Retinoid [EPC],Retinoids [Chemical/Ingredient] |