Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062777
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL 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
08/06/1987 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
12/21/1999 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/01/1997 SUPPL-12 Labeling

Label is not available on this site.

01/27/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/15/1993 SUPPL-9 Labeling

Label is not available on this site.

04/03/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/08/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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