Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074447
Company: BAUSCH AND LOMB
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 | None | No | Yes |
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. |