Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073630
Company: GENUS
Company: GENUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM | EQ 0.23% PHOSPHATE;10% | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/1993 | 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 |
|---|---|---|---|---|---|
| 12/11/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/16/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/21/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |