Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062367
Company: ACP NIMBLE

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 ACP NIMBLE
NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM;TOPICAL Prescription No AT 209990 AMNEAL PHARMS LLC
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 LABS LTD
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

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