Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075284
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75284ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075284.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |