Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062427
Company: TARO
Company: TARO
| 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 |
|---|---|---|---|---|---|---|---|
| 05/26/1983 | 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 |
|---|---|---|---|---|---|
| 07/05/1996 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 07/05/1996 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 08/27/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 06/26/1992 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 04/22/1992 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 07/30/1991 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/15/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 07/24/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 11/16/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/09/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/20/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |