Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215017
Company: MSN
Company: MSN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OBETICHOLIC ACID | OBETICHOLIC ACID | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| OBETICHOLIC ACID | OBETICHOLIC ACID | 10MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215017Orig1s000TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215017Orig1s000ltr.pdf |