Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064013
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 250MG TABLET, CHEWABLE;ORAL Prescription None No Yes
AMOXICILLIN AMOXICILLIN 125MG TABLET, CHEWABLE;ORAL Prescription 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
12/22/1992 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
05/18/2017 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

05/18/2017 SUPPL-55 Labeling-Package Insert

Label is not available on this site.

09/10/2015 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

02/02/2009 SUPPL-45 Labeling

Label is not available on this site.

07/17/2008 SUPPL-44 Labeling

Label is not available on this site.

05/31/2007 SUPPL-41 Labeling

Label is not available on this site.

08/29/2003 SUPPL-36 Labeling

Label is not available on this site.

12/09/2002 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

09/10/2002 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2002 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2002 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2002 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

07/13/2001 SUPPL-26 Labeling

Label is not available on this site.

09/10/2001 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/2001 SUPPL-21 Labeling

Label is not available on this site.

05/15/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/07/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

06/12/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1999 SUPPL-16 Labeling

Label is not available on this site.

08/28/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/01/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/12/1993 SUPPL-7 Labeling

Label is not available on this site.

08/26/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/12/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/13/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/11/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/11/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/11/1995 SUPPL-1 Labeling

Label is not available on this site.

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