Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062351
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
02/18/1982 | 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 |
---|---|---|---|---|---|
12/04/2009 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
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05/21/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/26/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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03/14/2002 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/21/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
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07/13/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
GENTAMICIN SULFATE
OINTMENT;TOPICAL; EQ 0.1% BASE
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 064054 | COSETTE |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 062533 | FOUGERA PHARMS INC |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 062351 | PADAGIS US |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AT | 062477 | TARO |