Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020896
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XELODA CAPECITABINE 150MG TABLET;ORAL Prescription AB Yes No
XELODA CAPECITABINE 500MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20896lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20896ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20896.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020896s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020896Orig1s039ltr.pdf
12/22/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/20/2015 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s037ltr.pdf
03/02/2015 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s036ltr.pdf
01/05/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/16/2014 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020896s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020896Orig1s034ltr.pdf
07/22/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/10/2013 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020896s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020896Orig1s032ltr.pdf
02/05/2011 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020896s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020896s026ltr.pdf
06/15/2005 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020896s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020896s016ltr.pdf
03/15/2003 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20896slr012_xeloda_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20896slr012ltr.pdf
09/07/2001 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-896S10S11_Xeloda.cfm
09/07/2001 SUPPL-10 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-896S10S11_Xeloda.cfm
04/30/2001 SUPPL-9 Labeling Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.cfm
03/24/2000 SUPPL-7 Labeling

Label is not available on this site.

04/30/2001 SUPPL-6 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20896s6_Xeloda.cfm
08/17/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1999 SUPPL-4 Labeling

Label is not available on this site.

02/04/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020896s039lbl.pdf
03/20/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf
03/02/2015 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s036lbl.pdf
10/16/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020896s034lbl.pdf
12/10/2013 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020896s032lbl.pdf
02/05/2011 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020896s026lbl.pdf
06/15/2005 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020896s016lbl.pdf
03/15/2003 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20896slr012_xeloda_lbl.pdf
09/07/2001 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf
09/07/2001 SUPPL-10 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S1011lbl.pdf
04/30/2001 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20896S6lbl.pdf
04/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20896lbl.pdf

XELODA

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 204741 AMNEAL PHARMS
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 090943 MYLAN PHARMS INC
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 207456 SHILPA MEDICARE LTD
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 204741 AMNEAL PHARMS
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 090943 MYLAN PHARMS INC
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 207456 SHILPA MEDICARE LTD
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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