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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062058
Company: CHARTWELL

Products on ANDA 062058

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 062058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/1978	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
02/07/2011	SUPPL-8	Labeling		Label is not available on this site.
07/15/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062058

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

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