Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074035
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOPROFEN | KETOPROFEN | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| KETOPROFEN | KETOPROFEN | 75MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/31/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/08/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/03/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/26/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/20/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |