Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062364
Company: TARO
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 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
12/22/1987 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
09/04/2007 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

03/19/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/24/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-6 Labeling

Label is not available on this site.

03/16/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/19/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-3 Labeling

Label is not available on this site.

12/07/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/12/1988 SUPPL-1 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
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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