Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065434
Company: AUROBINDO PHARMA

Products on ANDA 065434

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 065434

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2008	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
02/11/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/11/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/28/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065434

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