Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLURBIPROFEN SODIUM | FLURBIPROFEN SODIUM | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
01/04/1995 | 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 |
---|---|---|---|---|---|
01/28/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
12/09/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
11/27/2001 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/30/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
03/07/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
06/27/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/28/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/18/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
06/07/1999 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/24/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/1998 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/28/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1998 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/08/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLURBIPROFEN SODIUM
SOLUTION/DROPS;OPHTHALMIC; 0.03%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLURBIPROFEN SODIUM | FLURBIPROFEN SODIUM | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 074447 | BAUSCH AND LOMB |
OCUFEN | FLURBIPROFEN SODIUM | 0.03% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 019404 | ALLERGAN |
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