Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062216
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXIL AMOXICILLIN 250MG CAPSULE;ORAL Prescription AB No No
AMOXIL AMOXICILLIN 250MG CAPSULE; ORAL Discontinued None No No
AMOXIL AMOXICILLIN 500MG CAPSULE;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
08/02/1979 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-38 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-36 Labeling

Label is not available on this site.

12/05/2014 SUPPL-34 Labeling

Label is not available on this site.

03/12/2009 SUPPL-33 Labeling

Label is not available on this site.

03/06/2009 SUPPL-32 Labeling

Label is not available on this site.

02/17/2009 SUPPL-31 Labeling

Label is not available on this site.

09/01/2005 SUPPL-30 Labeling

Label is not available on this site.

10/07/2004 SUPPL-29 Labeling

Label is not available on this site.

12/09/2002 SUPPL-28 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-20 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/04/1998 SUPPL-18 Labeling

Label is not available on this site.

05/16/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/22/1995 SUPPL-15 Labeling

Label is not available on this site.

04/19/1993 SUPPL-14 Labeling

Label is not available on this site.

04/24/1996 SUPPL-13 Labeling

Label is not available on this site.

08/04/1998 SUPPL-12 Labeling

Label is not available on this site.

03/31/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

AMOXIL

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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