Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214055
Company: VGYAAN
Company: VGYAAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SELEXIPAG | SELEXIPAG | 200MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 400MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 600MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 800MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1000MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1200MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1400MCG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1600MCG | 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 |
|---|---|---|---|---|---|---|---|
| 03/02/2023 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214055Orig1s000Corrected_TA_ltr.pdf |