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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091649
Company: TEVA PHARMS USA

Products on ANDA 091649

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 091649

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2013	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091649Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091649Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2023	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/27/2022	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/17/2019	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/17/2019	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/18/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/18/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/27/2015	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/05/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 091649

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091649Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 091649

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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