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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062524
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 500,000 UNITS TABLET;ORAL 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
11/26/1985 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
09/11/1992 SUPPL-8 Labeling

Label is not available on this site.

07/16/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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