Application 213571
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0245-0575 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0245-0575 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 68308-575 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA | Current |
| 68308-575 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA | Current |
| 68308-575 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA | Current |
| 68308-575 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76355 | ORIG | 2023-11-06 |