Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062766
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE 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
03/03/1987 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
08/20/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/04/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/21/1992 SUPPL-4 Labeling

Label is not available on this site.

04/21/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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