Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060517
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUNGIZONE AMPHOTERICIN B 50MG/VIAL INJECTABLE;INJECTION 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
03/01/1966 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
11/07/2002 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

11/07/2002 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/07/2002 SUPPL-22 Labeling

Label is not available on this site.

11/07/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

11/16/1998 SUPPL-20 Labeling

Label is not available on this site.

09/25/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/09/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/09/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/24/1994 SUPPL-16 Labeling

Label is not available on this site.

03/31/1992 SUPPL-13 Labeling

Label is not available on this site.

05/20/1992 SUPPL-12 Labeling

Label is not available on this site.

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