Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062196
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 07/02/1980 | 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 |
|---|---|---|---|---|---|
| 12/23/2002 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1995 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
GENTAMICIN SULFATE
SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064048 | BAUSCH AND LOMB INC |
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 062196 | SANDOZ |