Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062615
Company: ODYSSEY PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS TABLET;VAGINAL 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
10/17/1985 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
05/24/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

10/05/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/13/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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