Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022470
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEXCEDE | KETOPROFEN | 12.5MG | FILM;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 |
|---|---|---|---|---|---|---|---|
| 11/25/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022470s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022470_nexcede_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022470s000sumr.pdf |