Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062531
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/05/1984 | 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 |
|---|---|---|---|---|---|
| 10/29/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/19/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/02/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |