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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065340
Company: AUROBINDO PHARMA

Products on ANDA 065340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	AB	No	No
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2007	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
05/15/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/05/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065340

CEFPROZIL

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	No	AB	090857	ALKEM LABS LTD
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	No	AB	065327	APOTEX INC
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	No	AB	065340	AUROBINDO PHARMA
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	No	AB	065235	CHARTWELL RX
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	No	AB	065276	LUPIN
CEFPROZIL	CEFPROZIL	250MG	TABLET;ORAL	Prescription	No	AB	065208	TEVA

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	No	AB	090857	ALKEM LABS LTD
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	No	AB	065327	APOTEX INC
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	No	AB	065340	AUROBINDO PHARMA
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	No	AB	065235	CHARTWELL RX
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	No	AB	065276	LUPIN
CEFPROZIL	CEFPROZIL	500MG	TABLET;ORAL	Prescription	No	AB	065208	TEVA

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