Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212489
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ONGENTYS | OPICAPONE | 25MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| ONGENTYS | OPICAPONE | 50MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/24/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212489s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212489Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212489Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/24/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212489s000lbl.pdf |