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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065235
Company: CHARTWELL RX

Products on ANDA 065235

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 065235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/065235ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/08/2008	SUPPL-8	Labeling		Label is not available on this site.
10/11/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065235

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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