Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022043
Company: JANSSEN LP
Company: JANSSEN LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
| INVEGA | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
| INVEGA | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
| INVEGA | PALIPERIDONE | 12MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022043s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022043_invega_toc.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/27/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022043lbl.pdf |