Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
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 |
---|---|---|---|---|---|---|---|
05/31/1995 | 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 |
---|---|---|---|---|---|
07/29/2002 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/12/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/12/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/20/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/20/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/20/2000 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
12/20/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/28/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/23/1999 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/09/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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