Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062613
Company: PADDOCK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100% POWDER;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
03/26/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/27/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/28/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/04/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/18/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/03/1995 SUPPL-2 Labeling

Label is not available on this site.

02/03/1995 SUPPL-1 Labeling

Label is not available on this site.

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