Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208002
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Discontinued | None | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/03/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208002Orig1s000ltr.pdf |