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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217607
Company: AUROBINDO PHARMA LTD

Products on ANDA 217607

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFIXIME	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217607

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217607

CEFIXIME

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFIXIME	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	No	AB	210574	ALKEM LABS LTD
CEFIXIME	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	No	AB	217607	AUROBINDO PHARMA LTD
SUPRAX	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	Yes	AB	203195	LUPIN LTD

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