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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065392
Company: LUPIN

Products on ANDA 065392

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065392

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2007	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
12/13/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065392

CEFADROXIL

CAPSULE;ORAL; EQ 500MG BASE
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	CAPSULE;ORAL	Prescription	No	AB	065352	AUROBINDO PHARMA
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065392	LUPIN
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065282	TEVA PHARMS

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