Drugs@FDA: FDA-Approved Drugs
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYKACET | 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 |
---|---|---|---|---|---|---|---|
05/28/1985 | 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 |
---|---|---|---|---|---|
05/30/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/29/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/16/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/28/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/07/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/10/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/10/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/28/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/22/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/22/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
12/22/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
MYKACET
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 |
---|---|---|---|---|---|---|---|---|
MYKACET | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 062367 | COSETTE |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 214090 | ALEOR DERMACEUTICALS |
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 | 208479 | PERRIGO UK FINCO |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 062364 | TARO |
NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | Prescription | No | AT | 213142 | TORRENT |
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