Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062683
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHRADINE CEPHRADINE 250MG CAPSULE;ORAL Discontinued None No No
CEPHRADINE CEPHRADINE 500MG 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
01/09/1987 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
07/07/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

10/19/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/03/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/21/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/21/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/15/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/15/1993 SUPPL-20 Labeling

Label is not available on this site.

03/01/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/20/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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