Amnesteem - isotretinoin
Navigation: NDC > Supplier starting with: M > MYLAN PHARMACEUTICALS INC.| Field | Value |
|---|---|
| NDC Code: | 0378-6614 |
| Proprietary Name: | Amnesteem |
| Suffix: | |
| Non-Proprietary Name: | isotretinoin |
| Dosage Form: | CAPSULE |
| Method: | ORAL |
| Original Marketing Date: | 11-11-2002 |
| Category Name: | ANDA |
| Application Number: | ANDA075945 |
| Labeler: | MYLAN PHARMACEUTICALS INC. |
| Substance Name: | ISOTRETINOIN |
| Active Numerator Strength: | 40 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Retinoid [EPC],Retinoids [Chemical/Ingredient] |
| DEA Schedule: |