Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062533
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 | OINTMENT;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
10/05/1984 | 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-6 | Labeling |
Label is not available on this site. |
||
03/19/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/07/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/02/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/26/1989 | SUPPL-2 | 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 |