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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211535
Company: CIPLA

Products on ANDA 211535

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	AB	No	No
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211535

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211535

DAPAGLIFLOZIN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211523	AIZANT
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211482	AJANTA PHARMA LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211560	ALEMBIC
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211545	ALKEM LABS LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211468	AUROBINDO PHARMA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211470	BIOCON PHARMA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211535	CIPLA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211156	INVENTIA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211531	LUPIN LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211506	MACLEODS PHARMS LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211467	MICRO LABS
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211478	MSN
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211312	SANDOZ
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211541	TEVA PHARMS USA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	No	AB	211582	ZYDUS PHARMS
FARXIGA	DAPAGLIFLOZIN	5MG	TABLET;ORAL	Prescription	Yes	AB	202293	ASTRAZENECA AB

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211523	AIZANT
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211482	AJANTA PHARMA LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211560	ALEMBIC
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211545	ALKEM LABS LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211468	AUROBINDO PHARMA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211470	BIOCON PHARMA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211535	CIPLA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211156	INVENTIA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211531	LUPIN LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211506	MACLEODS PHARMS LTD
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211467	MICRO LABS
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211478	MSN
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211312	SANDOZ
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211541	TEVA PHARMS USA
DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	No	AB	211582	ZYDUS PHARMS
FARXIGA	DAPAGLIFLOZIN	10MG	TABLET;ORAL	Prescription	Yes	AB	202293	ASTRAZENECA AB

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