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Drugs@FDA: FDA-Approved Drugs

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

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 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 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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