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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207058
Company: DR REDDYS LABS SA

Products on ANDA 207058

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 207058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207058Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207058Orig1s000ltr.pdf

Labels for ANDA 207058

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207058Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207058

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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