Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064031
Company: TEVA
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
12/19/1996 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
02/01/2000 SUPPL-5 Labeling

Label is not available on this site.

02/02/2000 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/13/1999 SUPPL-2 Labeling

Label is not available on this site.

07/07/1999 SUPPL-1 Labeling

Label is not available on this site.

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