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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212750
Company: GRANULES

Products on ANDA 212750

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	AB	No	No
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	AB	No	No
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212750

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212750

DOFETILIDE

CAPSULE;ORAL; 0.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOFETILDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	210740	AUROBINDO PHARMA LTD
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	213338	ACCORD HLTHCARE
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	208625	BIONPHARMA
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	207058	DR REDDYS LABS SA
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	212750	GRANULES
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	213220	MSN
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	207746	SIGMAPHARM LABS LLC
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	208519	STRIDES PHARMA
DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	No	AB	210466	SUN PHARM
TIKOSYN	DOFETILIDE	0.125MG	CAPSULE;ORAL	Prescription	Yes	AB	020931	PFIZER

CAPSULE;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOFETILDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	210740	AUROBINDO PHARMA LTD
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	213338	ACCORD HLTHCARE
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	208625	BIONPHARMA
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	207058	DR REDDYS LABS SA
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	212750	GRANULES
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	213220	MSN
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	207746	SIGMAPHARM LABS LLC
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	208519	STRIDES PHARMA
DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	No	AB	210466	SUN PHARM
TIKOSYN	DOFETILIDE	0.25MG	CAPSULE;ORAL	Prescription	Yes	AB	020931	PFIZER

CAPSULE;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOFETILDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	210740	AUROBINDO PHARMA LTD
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	213338	ACCORD HLTHCARE
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	208625	BIONPHARMA
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	207058	DR REDDYS LABS SA
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	212750	GRANULES
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	213220	MSN
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	207746	SIGMAPHARM LABS LLC
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	208519	STRIDES PHARMA
DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	210466	SUN PHARM
TIKOSYN	DOFETILIDE	0.5MG	CAPSULE;ORAL	Prescription	Yes	AB	020931	PFIZER

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