Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090857
Company: ALKEM LABS LTD

Products on ANDA 090857

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 090857

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2024	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090857

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