Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065351
Company: APOTEX INC

Products on ANDA 065351

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065351

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/29/2012	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
05/12/2017	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065351

CEFPROZIL

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFPROZIL	CEFPROZIL	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065351	APOTEX INC
CEFPROZIL	CEFPROZIL	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065381	AUROBINDO PHARMA
CEFPROZIL	CEFPROZIL	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065261	LUPIN

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFPROZIL	CEFPROZIL	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065351	APOTEX INC
CEFPROZIL	CEFPROZIL	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065381	AUROBINDO PHARMA
CEFPROZIL	CEFPROZIL	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065261	LUPIN