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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065396
Company: LUPIN

Products on ANDA 065396

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065396

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2008	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065396s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf

Labels for ANDA 065396

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf
02/21/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf

Therapeutic Equivalents for ANDA 065396

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

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