Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211774
Company: SHILPA MEDICARE LTD
Company: SHILPA MEDICARE LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APREMILAST | APREMILAST | 10MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| APREMILAST | APREMILAST | 20MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| APREMILAST | APREMILAST | 30MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/04/2021 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211774Orig1s000TAltr.pdf |
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