Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062347
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 Discontinued None 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
03/30/1987 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
04/29/1993 SUPPL-25 Labeling

Label is not available on this site.

04/29/1993 SUPPL-24 Labeling

Label is not available on this site.

11/25/1992 SUPPL-22 Labeling

Label is not available on this site.

11/25/1992 SUPPL-21 Labeling

Label is not available on this site.

02/20/1992 SUPPL-20 Labeling

Label is not available on this site.

07/31/1991 SUPPL-19 Labeling

Label is not available on this site.

12/31/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/31/1991 SUPPL-15 Labeling

Label is not available on this site.

07/31/1991 SUPPL-14 Labeling

Label is not available on this site.

06/30/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/24/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/24/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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