Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020896
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| 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 |
|---|---|---|---|---|---|
| 12/14/2022 | SUPPL-51 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-50 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-49 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-48 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-47 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-46 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-45 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 12/14/2022 | SUPPL-44 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020896Orig1s044,s045,s046,s047,s048,s049,s050,s051.pdf | |
| 05/19/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020896s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020896Orig1s043ltr.pdf | |
| 02/22/2019 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020896Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020896Orig1s042ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/14/2022 | SUPPL-51 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-50 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-49 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-48 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-47 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-46 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-45 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 12/14/2022 | SUPPL-44 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf | |
| 05/19/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020896s043lbl.pdf | |
| 02/22/2019 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020896Orig1s042lbl.pdf | |
| 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 | 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 |