An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200483
Company: HIKMA

Products on ANDA 200483

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 200483

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2016	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/12/2022	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
10/15/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/11/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/11/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200483

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

Top