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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065322
Company: HIKMA

Products on ANDA 065322

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065322

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2006	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
12/02/2014	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/07/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/30/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065322

AMOXICILLIN

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	204030	AUROBINDO PHARMA LTD
AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065322	HIKMA
AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065387	SANDOZ
AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	061931	TEVA
AMOXIL	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	062226	US ANTIBIOTICS
LAROTID	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	062226	US ANTIBIOTICS

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	204030	AUROBINDO PHARMA LTD
AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065322	HIKMA
AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065387	SANDOZ
AMOXIL	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	062226	US ANTIBIOTICS
LAROTID	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	062226	US ANTIBIOTICS

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