Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062226
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXIL AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXIL AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXIL AMOXICILLIN 50MG/ML FOR SUSPENSION;ORAL Prescription AB No No
LAROTID AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
LAROTID AMOXICILLIN 250MG/5ML 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
11/27/1979 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-39 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-37 Labeling

Label is not available on this site.

12/05/2014 SUPPL-35 Labeling

Label is not available on this site.

03/12/2009 SUPPL-34 Labeling

Label is not available on this site.

03/06/2009 SUPPL-33 Labeling

Label is not available on this site.

02/17/2009 SUPPL-32 Labeling

Label is not available on this site.

09/01/2005 SUPPL-31 Labeling

Label is not available on this site.

10/07/2004 SUPPL-30 Labeling

Label is not available on this site.

12/09/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/2001 SUPPL-27 Labeling

Label is not available on this site.

05/31/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1999 SUPPL-23 Labeling

Label is not available on this site.

04/20/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/24/1997 SUPPL-21 Labeling

Label is not available on this site.

08/04/1998 SUPPL-20 Labeling

Label is not available on this site.

05/22/1995 SUPPL-18 Labeling

Label is not available on this site.

04/19/1993 SUPPL-17 Labeling

Label is not available on this site.

02/11/1992 SUPPL-16 Labeling

Label is not available on this site.

08/04/1998 SUPPL-15 Labeling

Label is not available on this site.

03/09/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/23/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/24/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

AMOXIL

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

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

LAROTID

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

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