Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212330
Company: INVAGEN PHARMS

Products on ANDA 212330

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMPAGLIFLOZIN	EMPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	AB	No	No
EMPAGLIFLOZIN	EMPAGLIFLOZIN	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212330

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212330

EMPAGLIFLOZIN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMPAGLIFLOZIN	EMPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	212330	INVAGEN PHARMS
JARDIANCE	EMPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	Yes	AB	204629	BOEHRINGER INGELHEIM

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMPAGLIFLOZIN	EMPAGLIFLOZIN	25MG	TABLET;ORAL	Prescription	No	AB	212330	INVAGEN PHARMS
JARDIANCE	EMPAGLIFLOZIN	25MG	TABLET;ORAL	Prescription	Yes	AB	204629	BOEHRINGER INGELHEIM