Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208829
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Discontinued | None | No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/24/2017 | ORIG-1 | Approval | STANDARD |
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