Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065349
Company: AUROBINDO

Products on ANDA 065349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2013	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
04/18/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065349

CEFADROXIL

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065349	AUROBINDO
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065396	LUPIN

FOR SUSPENSION;ORAL; EQ 500MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065349	AUROBINDO
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065396	LUPIN