Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 062216
Company: US ANTIBIOTICS

Products on ANDA 062216

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062216

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	Note
05/01/2024	SUPPL-44	Labeling-Package Insert	Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 062216

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	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