Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091649
Company: TEVA PHARMS USA
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
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
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-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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

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 204741 AMNEAL PHARMS
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 210604 EUGIA PHARMA
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 209365 MSN LABS PVT LTD
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 090943 MYLAN
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 207456 SHILPA MEDICARE LTD
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 200483 WEST-WARD PHARMS INT
XELODA CAPECITABINE 150MG TABLET;ORAL Prescription Yes AB 020896 HOFFMANN LA ROCHE

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 204741 AMNEAL PHARMS
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 210604 EUGIA PHARMA
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 209365 MSN LABS PVT LTD
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 090943 MYLAN
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 207456 SHILPA MEDICARE LTD
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 200483 WEST-WARD PHARMS INT
XELODA CAPECITABINE 500MG TABLET;ORAL Prescription Yes AB 020896 HOFFMANN LA ROCHE

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