Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064076
Company: SANDOZ

Products on ANDA 064076

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064076

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
05/01/2024	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
04/25/2024	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
06/03/2020	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
06/03/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 064076

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	065271	AUROBINDO
AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE;ORAL	Prescription	No	AB	062058	CHARTWELL
AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE;ORAL	Prescription	No	AB	065291	HIKMA PHARMS
AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE;ORAL	Prescription	No	AB	207471	MICRO LABS
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	US ANTIBIOTICS

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	065271	AUROBINDO
AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE;ORAL	Prescription	No	AB	062058	CHARTWELL
AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE;ORAL	Prescription	No	AB	065291	HIKMA PHARMS
AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE;ORAL	Prescription	No	AB	207471	MICRO LABS
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	US ANTIBIOTICS