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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065378
Company: SANDOZ

Products on ANDA 065378

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065378

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2007	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
06/03/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/03/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/25/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/22/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065378

AMOXICILLIN

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065334	AUROBINDO
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065325	HIKMA
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065378	SANDOZ
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065119	TEVA

FOR SUSPENSION;ORAL; 400MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065334	AUROBINDO
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065325	HIKMA
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065378	SANDOZ
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065119	TEVA
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065319	WOCKHARDT BIO AG
AMOXIL	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050760	US ANTIBIOTICS

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