Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ INC
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 | 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 |
---|---|---|---|---|---|---|---|
07/02/1980 | 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 |
---|---|---|---|---|---|---|---|---|
GENOPTIC | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 062452 | ALLERGAN |
GENTAK | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064163 | AKORN |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 062635 | AKORN |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064048 | BAUSCH AND LOMB |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 065121 | PADAGIS US |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 062196 | SANDOZ INC |
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