Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074879
Company: ALKERMES GAINESVILLE
Company: ALKERMES GAINESVILLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOPROFEN | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/10/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74879.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |