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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211865
Company: SUNSHINE

Products on ANDA 211865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211865

RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208862	ACTAVIS ELIZABETH
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210054	AJANTA PHARMA LTD
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209953	ALKEM LABS LTD
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209081	AUROBINDO PHARMA
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210188	CADILA
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201046	CHARTWELL RX
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211082	GLENMARK PHARMS LTD
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212788	HETERO LABS LTD III
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213517	I3 PHARMS
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212284	MANKIND PHARMA
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211745	MICRO LABS
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210668	NOVAST LABS
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212781	PRAXGEN
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212889	RISING
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211829	SCIEGEN PHARMS INC
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211707	SUN PHARM
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211865	SUNSHINE
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213083	UNICHEM
RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214035	VKT PHARMA

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208862	ACTAVIS ELIZABETH
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210054	AJANTA PHARMA LTD
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209953	ALKEM LABS LTD
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209081	AUROBINDO PHARMA
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210188	CADILA
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201046	CHARTWELL RX
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211082	GLENMARK PHARMS LTD
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212788	HETERO LABS LTD III
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213517	I3 PHARMS
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212284	MANKIND PHARMA
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211745	MICRO LABS
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210668	NOVAST LABS
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212781	PRAXGEN
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212889	RISING
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211829	SCIEGEN PHARMS INC
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211707	SUN PHARM
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211865	SUNSHINE
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213083	UNICHEM
RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214035	VKT PHARMA

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