Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087442
Company: BEDFORD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOSAR CYCLOPHOSPHAMIDE 100MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NEOSAR CYCLOPHOSPHAMIDE 200MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NEOSAR CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NEOSAR CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Discontinued None No No
NEOSAR CYCLOPHOSPHAMIDE 2GM/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
02/16/1982 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
03/25/2002 SUPPL-22 Labeling

Label is not available on this site.

03/03/1997 SUPPL-21 Labeling

Label is not available on this site.

08/19/1993 SUPPL-20 Labeling

Label is not available on this site.

08/06/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-18 Labeling

Label is not available on this site.

01/30/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/13/1990 SUPPL-16 Labeling

Label is not available on this site.

03/30/1989 SUPPL-15 Labeling

Label is not available on this site.

03/30/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/30/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/30/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/18/1988 SUPPL-11 Labeling

Label is not available on this site.

02/12/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/08/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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