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Amnesteem
Amnesteem - 0378-6614-93 - (isotretinoin)
Drug Information of Amnesteem
| Product NDC: | 0378-6614 |
| Proprietary Name: | Amnesteem |
| Non Proprietary Name: | isotretinoin |
| Active Ingredient(s): | 40 mg/1 & nbsp; isotretinoin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Amnesteem
| Product NDC: | 0378-6614 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075945 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120523 |
Package Information of Amnesteem
| Package NDC: | 0378-6614-93 |
| Package Description: | 3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK |
NDC Information of Amnesteem
| NDC Code | 0378-6614-93 |
| Proprietary Name | Amnesteem |
| Package Description | 3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK |
| Product NDC | 0378-6614 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | isotretinoin |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120523 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | ISOTRETINOIN |
| Strength Number | 40 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Retinoid [EPC],Retinoids [Chemical/Ingredient] |
