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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201046
Company: CHARTWELL RX

Products on ANDA 201046

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 201046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2013	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201046Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2020	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/18/2020	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/25/2020	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/25/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/25/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201046

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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