Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062599
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;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 |
---|---|---|---|---|---|---|---|
10/08/1985 | 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 |
---|---|---|---|---|---|
03/14/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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06/18/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/28/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/18/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
NYSTATIN AND TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL; 100,000 UNITS/GM;0.1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 214090 | ALEMBIC |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 209990 | AMNEAL |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 207730 | CROWN LABS INC |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 208326 | DR REDDYS |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 062599 | FOUGERA PHARMS INC |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 208136 | GLENMARK PHARMS LTD |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 208205 | LUPIN LTD |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 214181 | MACLEODS PHARMS LTD |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 208479 | PADAGIS ISRAEL |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 062364 | TARO |