Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062205
Company: CEPH INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFACLOR CEFACLOR EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
CEFACLOR CEFACLOR EQ 500MG BASE CAPSULE;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
07/28/1979 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
05/01/2000 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2000 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2000 SUPPL-49 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/23/1999 SUPPL-48 Manufacturing (CMC)-Facility

Label is not available on this site.

08/30/1999 SUPPL-47 Labeling

Label is not available on this site.

03/03/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/30/1998 SUPPL-45 Labeling

Label is not available on this site.

01/30/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

10/23/1997 SUPPL-42 Labeling

Label is not available on this site.

04/01/1997 SUPPL-41 Labeling

Label is not available on this site.

06/10/1996 SUPPL-37 Labeling

Label is not available on this site.

04/07/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/02/1994 SUPPL-35 Labeling

Label is not available on this site.

05/24/1994 SUPPL-32 Labeling

Label is not available on this site.

06/23/1992 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/23/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/13/1994 SUPPL-29 Labeling

Label is not available on this site.

12/03/1992 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/19/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/26/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

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