Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062768
Company: TEVA
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
06/16/1987 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
09/11/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/15/1998 SUPPL-18 Labeling

Label is not available on this site.

08/20/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/16/1996 SUPPL-16 Labeling

Label is not available on this site.

07/03/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-12 Labeling

Label is not available on this site.

06/28/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/07/1993 SUPPL-10 Labeling

Label is not available on this site.

06/04/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/13/1993 SUPPL-8 Labeling

Label is not available on this site.

06/04/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/30/1992 SUPPL-6 Labeling

Label is not available on this site.

02/27/1992 SUPPL-5 Labeling

Label is not available on this site.

03/24/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/13/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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