Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061926
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription AB 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
02/09/1976 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-128 Labeling-Package Insert

Label is not available on this site.

05/18/2017 SUPPL-127 Labeling-Package Insert

Label is not available on this site.

09/10/2015 SUPPL-121 Labeling-Package Insert

Label is not available on this site.

02/02/2009 SUPPL-117 Labeling

Label is not available on this site.

07/17/2008 SUPPL-116 Labeling

Label is not available on this site.

05/31/2007 SUPPL-113 Labeling

Label is not available on this site.

07/30/2003 SUPPL-110 Labeling

Label is not available on this site.

11/20/2002 SUPPL-106 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/20/2002 SUPPL-105 Manufacturing (CMC)-Facility

Label is not available on this site.

03/14/2002 SUPPL-102 Manufacturing (CMC)-Facility

Label is not available on this site.

04/19/2002 SUPPL-101 Manufacturing (CMC)-Facility

Label is not available on this site.

04/19/2002 SUPPL-100 Manufacturing (CMC)-Facility

Label is not available on this site.

07/13/2001 SUPPL-99 Labeling

Label is not available on this site.

09/17/2001 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/2001 SUPPL-97 Labeling

Label is not available on this site.

07/24/2001 SUPPL-96 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2001 SUPPL-95 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2001 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

07/07/2000 SUPPL-93 Manufacturing (CMC)-Facility

Label is not available on this site.

04/06/1999 SUPPL-91 Labeling

Label is not available on this site.

12/10/1997 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

06/30/1995 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

11/26/1993 SUPPL-85 Labeling

Label is not available on this site.

06/28/1993 SUPPL-83 Labeling

Label is not available on this site.

09/02/1993 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

08/14/1992 SUPPL-81 Labeling

Label is not available on this site.

03/28/1989 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

AMOXICILLIN

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 062058 AM ANTIBIOTICS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 065271 AUROBINDO
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 062884 DAVA PHARMS INC
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 065291 HIKMA PHARMS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 064076 SANDOZ
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 061926 TEVA
AMOXIL AMOXICILLIN 250MG CAPSULE;ORAL Prescription No AB 062216 DR REDDYS LABS INC

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 062058 AM ANTIBIOTICS
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 065271 AUROBINDO
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 062881 DAVA PHARMS INC
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 065291 HIKMA PHARMS
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 064076 SANDOZ
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 061926 TEVA
AMOXIL AMOXICILLIN 500MG CAPSULE;ORAL Prescription No AB 062216 DR REDDYS LABS INC

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