Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210386
Company: AUROBINDO PHARMA LTD

Products on ANDA 210386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CANAGLIFLOZIN	CANAGLIFLOZIN	100MG	TABLET;ORAL	Prescription	AB	No	No
CANAGLIFLOZIN	CANAGLIFLOZIN	300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210386

CANAGLIFLOZIN

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CANAGLIFLOZIN	CANAGLIFLOZIN	100MG	TABLET;ORAL	Prescription	No	AB	210449	APOTEX
CANAGLIFLOZIN	CANAGLIFLOZIN	100MG	TABLET;ORAL	Prescription	No	AB	210386	AUROBINDO PHARMA LTD
INVOKANA	CANAGLIFLOZIN	100MG	TABLET;ORAL	Prescription	Yes	AB	204042	JANSSEN PHARMS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CANAGLIFLOZIN	CANAGLIFLOZIN	300MG	TABLET;ORAL	Prescription	No	AB	210449	APOTEX
CANAGLIFLOZIN	CANAGLIFLOZIN	300MG	TABLET;ORAL	Prescription	No	AB	210386	AUROBINDO PHARMA LTD
INVOKANA	CANAGLIFLOZIN	300MG	TABLET;ORAL	Prescription	Yes	AB	204042	JANSSEN PHARMS