Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210201
Company: ACQ PHARMA
Company: ACQ PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
MISOPROSTOL | MISOPROSTOL | 0.2MG | 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 |
---|---|---|---|---|---|---|---|
07/02/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |