Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064076
Company: SANDOZ
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 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
09/30/1994 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
11/25/2014 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

02/22/2013 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

05/31/2007 SUPPL-18 Labeling

Label is not available on this site.

05/31/2007 SUPPL-17 Labeling

Label is not available on this site.

05/10/2006 SUPPL-16 Labeling

Label is not available on this site.

09/09/2005 SUPPL-14 Labeling

Label is not available on this site.

09/30/2004 SUPPL-12 Labeling

Label is not available on this site.

09/30/2004 SUPPL-11 Labeling

Label is not available on this site.

04/06/2004 SUPPL-10 Labeling

Label is not available on this site.

04/12/2001 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/21/2000 SUPPL-6 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/07/2000 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/14/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-1 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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