Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050313
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUNGIZONE AMPHOTERICIN B 3% OINTMENT;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
10/13/1965 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/1997 SUPPL-21 Labeling

Label is not available on this site.

06/25/1997 SUPPL-17 Labeling

Label is not available on this site.

02/08/1979 SUPPL-13 Labeling

Label is not available on this site.

02/13/1975 SUPPL-12 Labeling

Label is not available on this site.

04/06/1973 SUPPL-11 Labeling

Label is not available on this site.

11/26/1971 SUPPL-10 Labeling

Label is not available on this site.

04/23/1971 SUPPL-9 Labeling

Label is not available on this site.

01/12/1971 SUPPL-7 Labeling

Label is not available on this site.

12/29/1970 SUPPL-6 Labeling

Label is not available on this site.

06/16/1967 SUPPL-2 Labeling

Label is not available on this site.

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