Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065264
Company: LUPIN

Products on ANDA 065264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065264s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/01/2010	SUPPL-9	Labeling		Label is not available on this site.
06/11/2008	SUPPL-4	Labeling		Label is not available on this site.
12/20/2007	SUPPL-3	Labeling		Label is not available on this site.
09/07/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065264

CEFDINIR

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	No	AB	210220	ALKEM LABS LTD
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	No	AB	065418	ANDA REPOSITORY
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	No	AB	065434	AUROBINDO PHARMA
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	No	AB	065264	LUPIN
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	No	AB	065330	SANDOZ
CEFDINIR	CEFDINIR	300MG	CAPSULE;ORAL	Prescription	No	AB	065368	TEVA PHARMS