Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074358
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLURBIPROFEN | FLURBIPROFEN | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| FLURBIPROFEN | FLURBIPROFEN | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/1994 | 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-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/17/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/10/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 05/19/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/31/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/29/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |