Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062531
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
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 |
---|---|---|---|---|---|---|---|
07/05/1984 | 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 |
---|---|---|---|---|---|
10/29/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/19/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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12/29/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/02/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/26/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |