Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061769
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADYL CEPHAPIRIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFADYL CEPHAPIRIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFADYL CEPHAPIRIN SODIUM EQ 4GM BASE/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
03/12/1974 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
06/11/1993 SUPPL-15 Labeling

Label is not available on this site.

05/21/1991 SUPPL-14 Labeling

Label is not available on this site.

07/17/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/01/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/13/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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