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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207652
Company: ALKEM LABS LTD

Products on ANDA 207652

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	AB	No	No
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207652

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2019	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 207652

CAPECITABINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	202593	ACCORD HLTHCARE
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	207652	ALKEM LABS LTD
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	204345	DR REDDYS
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	210604	EUGIA PHARMA
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	210203	HETERO LABS LTD V
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	200483	HIKMA
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	209365	MSN
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	211724	RELIANCE LIFE
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	090943	RISING
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	207456	SHILPA
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	204668	SUN PHARM
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	091649	TEVA PHARMS USA
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	No	AB	217237	TEYRO LABS
XELODA	CAPECITABINE	150MG	TABLET;ORAL	Prescription	Yes	AB	020896	CHEPLAPHARM

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	202593	ACCORD HLTHCARE
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	207652	ALKEM LABS LTD
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	204345	DR REDDYS
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	210604	EUGIA PHARMA
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	210203	HETERO LABS LTD V
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	200483	HIKMA
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	209365	MSN
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	211724	RELIANCE LIFE
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	090943	RISING
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	207456	SHILPA
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	204668	SUN PHARM
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	091649	TEVA PHARMS USA
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	No	AB	217237	TEYRO LABS
XELODA	CAPECITABINE	500MG	TABLET;ORAL	Prescription	Yes	AB	020896	CHEPLAPHARM

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