Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064139
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 125MG TABLET, CHEWABLE;ORAL Discontinued None No No
AMOXICILLIN AMOXICILLIN 250MG TABLET, CHEWABLE;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
01/29/1996 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
11/30/2001 SUPPL-11 Labeling

Label is not available on this site.

07/13/2001 SUPPL-10 Labeling

Label is not available on this site.

03/12/2001 SUPPL-9 Labeling

Label is not available on this site.

11/27/2000 SUPPL-8 Labeling

Label is not available on this site.

11/17/1999 SUPPL-7 Labeling

Label is not available on this site.

01/25/1999 SUPPL-5 Labeling

Label is not available on this site.

06/09/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/05/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/13/1997 SUPPL-2 Labeling

Label is not available on this site.

01/13/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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