Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061931
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription AB No Yes
AMOXICILLIN PEDIATRIC AMOXICILLIN 50MG/ML FOR SUSPENSION;ORAL Prescription AB 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
12/01/1982 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-49 Labeling-Package Insert

Label is not available on this site.

05/18/2017 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

09/10/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

02/02/2009 SUPPL-40 Labeling

Label is not available on this site.

07/17/2008 SUPPL-39 Labeling

Label is not available on this site.

05/31/2007 SUPPL-38 Labeling

Label is not available on this site.

04/19/2004 SUPPL-30 Labeling

Label is not available on this site.

11/07/2002 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

11/07/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2002 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/14/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

07/13/2001 SUPPL-20 Labeling

Label is not available on this site.

03/23/2001 SUPPL-19 Labeling

Label is not available on this site.

05/15/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

11/14/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

11/07/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1999 SUPPL-14 Labeling

Label is not available on this site.

12/22/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/02/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/27/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/18/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/06/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/17/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-3 Labeling

Label is not available on this site.

03/14/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

AMOXICILLIN

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 204030 AUROBINDO PHARMA LTD
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062927 DAVA PHARMS INC
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065322 HIKMA
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065387 SANDOZ
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 061931 TEVA
AMOXIL AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 DR REDDYS LABS INC
LAROTID AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 DR REDDYS LABS INC

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 204030 AUROBINDO PHARMA LTD
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062927 DAVA PHARMS INC
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065322 HIKMA
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065387 SANDOZ
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 061931 TEVA
AMOXIL AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 DR REDDYS LABS INC
LAROTID AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 DR REDDYS LABS INC

AMOXICILLIN PEDIATRIC

FOR SUSPENSION;ORAL; 50MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN PEDIATRIC AMOXICILLIN 50MG/ML FOR SUSPENSION;ORAL Prescription No AB 061931 TEVA
AMOXIL AMOXICILLIN 50MG/ML FOR SUSPENSION;ORAL Prescription No AB 062226 DR REDDYS LABS INC

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