Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062457
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/GM 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
07/28/1983 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
04/27/1993 SUPPL-21 Labeling

Label is not available on this site.

08/06/1993 SUPPL-20 Labeling

Label is not available on this site.

04/29/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/24/1992 SUPPL-17 Labeling

Label is not available on this site.

06/30/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/16/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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