Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062774
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 1GM BASE TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/08/1987 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
04/18/2012 SUPPL-16 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062774s016lbl.pdf
06/30/2008 SUPPL-14 Labeling

Label is not available on this site.

08/20/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/23/1999 SUPPL-9 Labeling

Label is not available on this site.

08/23/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/23/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/23/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/21/1992 SUPPL-3 Labeling

Label is not available on this site.

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

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/18/2012 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062774s016lbl.pdf

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