Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062477
Company: SUN PHARMA CANADA
Company: SUN PHARMA CANADA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 12/23/1983 | 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-24 | Labeling |
Label is not available on this site. |
||
| 07/05/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/18/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 08/27/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 08/05/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 11/19/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |