CELEBREX از شرکت UPJOHN

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CELEBREX از شرکت UPJOHN

New Drug Application (NDA): 020998

Company: UPJOHN

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CELEBREXCELECOXIB100MGCAPSULE;ORALPrescription

AB

YesNo
CELEBREXCELECOXIB200MGCAPSULE;ORALPrescription

AB

YesNo
CELEBREXCELECOXIB400MGCAPSULE;ORALPrescription

AB

YesYes
CELEBREXCELECOXIB50MGCAPSULE;ORALPrescription

AB

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
12/31/1998ORIG-1 Approval

Type 1 – New Molecular Entity

PRIORITY

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20998lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20998ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20998.cfm

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
04/28/2021SUPPL-56 Labeling-Package Insert, Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020998Orig1s056ltr.pdf

05/03/2019SUPPL-54 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020998s054lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020998Orig1s054ltr.pdf

06/28/2018SUPPL-50 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020998s050lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020998Orig1s050ltr.pdf

05/09/2016SUPPL-48 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020998s048lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048ltr.pdf

05/09/2016SUPPL-47 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048ltr.pdf

07/28/2014SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

07/29/2013SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/16/2012SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/04/2011SUPPL-33 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020998s033,021156s003ltr.pdf

12/31/2008SUPPL-27 Efficacy-New Dosing Regimen

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s027lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s027ltr.pdf

01/14/2008SUPPL-26 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s026ltr.pdf

11/02/2007SUPPL-23 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s023ltr.pdf

06/01/2007SUPPL-22 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020998s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s022ltr.pdf

12/15/2006SUPPL-21 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020998s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020998s021ltr.pdf

07/29/2005SUPPL-19 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf

07/29/2005SUPPL-18 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf

02/09/2005SUPPL-17 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20998s017ltr.pdf

01/09/2004SUPPL-16 Labeling

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20998slr016_celebrex_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20998slr016ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020998_s016_CelebrexTOC.cfm

09/16/2002SUPPL-14 Manufacturing (CMC)-Packaging

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020998_S014_CELEBREXTOC.cfm

08/29/2002SUPPL-13 Manufacturing (CMC)-Control

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998scs013ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-998s013_Celebrex.cfm

08/15/2001SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/2001SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2001SUPPL-10 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20998s10lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20998s10ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-998s010_Celebrex.cfm

06/07/2002SUPPL-9 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20998s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998s009ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-998s009_Celebrex.cfm

12/01/2000SUPPL-8 Labeling

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S008_CELEBREX.pdf

12/23/1999SUPPL-7 Labeling

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21156ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21156-S007_Celebrex.cfm

03/21/2000SUPPL-6 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S006_CELEBREX.pdf

02/17/2000SUPPL-4 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S004_CELEBREX.pdf

08/13/1999SUPPL-1 Manufacturing (CMC)-Packaging

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020998_S001_CELEBREX.pdf

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
04/28/2021SUPPL-56

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf
04/28/2021SUPPL-56

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf
05/03/2019SUPPL-54

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020998s054lbl.pdf
06/28/2018SUPPL-50

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020998s050lbl.pdf
05/09/2016SUPPL-48

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020998s048lbl.pdf
02/04/2011SUPPL-33

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf
12/31/2008SUPPL-27

Efficacy-New Dosing Regimen

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s027lbl.pdf
01/14/2008SUPPL-26

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s026lbl.pdf
06/01/2007SUPPL-22

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020998s022lbl.pdf
12/15/2006SUPPL-21

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020998s021lbl.pdf
07/29/2005SUPPL-19

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf
07/29/2005SUPPL-18

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf
02/09/2005SUPPL-17

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s017lbl.pdf
01/09/2004SUPPL-16

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20998slr016_celebrex_lbl.pdf
06/07/2002SUPPL-9

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20998s009lbl.pdf
10/18/2001SUPPL-10

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20998s10lbl.pdf
12/23/1999SUPPL-7

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf
12/31/1998ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20998lbl.pdf

CELEBREX

CAPSULE;ORAL; 100MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB100MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204197APOTEX INC
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB210071CSPC OUYI
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB211412YILING

CAPSULE;ORAL; 200MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB200MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204197APOTEX INC
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB210071CSPC OUYI
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB213598NANJING
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB211412YILING

CAPSULE;ORAL; 400MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB400MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB211412YILING

CAPSULE;ORAL; 50MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB50MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204197APOTEX INC
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB210071CSPC OUYI
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB211412YILING
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