Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENOPTIC | 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 |
---|---|---|---|---|---|---|---|
10/10/1984 | 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 |
---|---|---|---|---|---|
11/15/2002 | SUPPL-22 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
07/03/2002 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/15/2001 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
02/20/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
12/08/2000 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/16/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1998 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
01/31/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
07/01/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/28/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
02/26/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/11/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/22/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
GENOPTIC
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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