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CELEBREX از شرکت UPJOHN

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CELEBREX از شرکت UPJOHN

New Drug Application (NDA): 020998

Company: UPJOHN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CELEBREX CELECOXIB 100MG CAPSULE;ORAL Prescription

AB

Yes No
CELEBREX CELECOXIB 200MG CAPSULE;ORAL Prescription

AB

Yes No
CELEBREX CELECOXIB 400MG CAPSULE;ORAL Prescription

AB

Yes Yes
CELEBREX CELECOXIB 50MG CAPSULE;ORAL Prescription

AB

Yes 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
12/31/1998 ORIG-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 Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-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

05/03/2019 SUPPL-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

06/28/2018 SUPPL-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

05/09/2016 SUPPL-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

05/09/2016 SUPPL-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

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

02/04/2011 SUPPL-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

12/31/2008 SUPPL-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

01/14/2008 SUPPL-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

11/02/2007 SUPPL-23 Labeling

Letter (PDF)

Label is not available on this site.

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

06/01/2007 SUPPL-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

12/15/2006 SUPPL-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

07/29/2005 SUPPL-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

07/29/2005 SUPPL-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

02/09/2005 SUPPL-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

01/09/2004 SUPPL-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

09/16/2002 SUPPL-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

08/29/2002 SUPPL-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

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

Label is not available on this site.

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

Label is not available on this site.

10/18/2001 SUPPL-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

06/07/2002 SUPPL-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

12/01/2000 SUPPL-8 Labeling

Review (PDF)

Label is not available on this site.

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

12/23/1999 SUPPL-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

03/21/2000 SUPPL-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

02/17/2000 SUPPL-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

08/13/1999 SUPPL-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 Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2021 SUPPL-56

Labeling-Package Insert

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

Labeling-Medication Guide

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

Labeling-Package Insert

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

Efficacy-Labeling Change With Clinical Data

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

Labeling-Package Insert

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

Labeling

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

Efficacy-New Dosing Regimen

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

Labeling

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

Labeling

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

Efficacy-New Patient Population

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

Labeling

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

Efficacy-New Indication

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

Labeling

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

Labeling

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

Efficacy-Labeling Change With Clinical Data

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

Efficacy-New Indication

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

Labeling

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

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

CELEBREX

CAPSULE;ORAL; 100MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEBREX CELECOXIB 100MG CAPSULE;ORAL Prescription Yes AB 020998 UPJOHN
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204197 APOTEX INC
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 208701 CADILA PHARMS LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 207446 CIPLA
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 210071 CSPC OUYI
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 202240 LUPIN LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204590 MACLEODS PHARMS LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204776 MICRO LABS
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 078857 MYLAN
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 205129 SCIEGEN PHARMS INC
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 207872 TIANJIN TIANYAO
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 210628 UMEDICA LABS PVT LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 213301 UNICHEM
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 211412 YILING

CAPSULE;ORAL; 200MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEBREX CELECOXIB 200MG CAPSULE;ORAL Prescription Yes AB 020998 UPJOHN
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204197 APOTEX INC
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 208701 CADILA PHARMS LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 207446 CIPLA
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 210071 CSPC OUYI
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 202240 LUPIN LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204590 MACLEODS PHARMS LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204776 MICRO LABS
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 078857 MYLAN
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 213598 NANJING
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 205129 SCIEGEN PHARMS INC
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 207872 TIANJIN TIANYAO
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 210628 UMEDICA LABS PVT LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 213301 UNICHEM
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 211412 YILING

CAPSULE;ORAL; 400MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEBREX CELECOXIB 400MG CAPSULE;ORAL Prescription Yes AB 020998 UPJOHN
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 208701 CADILA PHARMS LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207446 CIPLA
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 202240 LUPIN LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 204590 MACLEODS PHARMS LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 204776 MICRO LABS
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 078857 MYLAN
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 205129 SCIEGEN PHARMS INC
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207872 TIANJIN TIANYAO
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 210628 UMEDICA LABS PVT LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 213301 UNICHEM
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 211412 YILING

CAPSULE;ORAL; 50MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELEBREX CELECOXIB 50MG CAPSULE;ORAL Prescription Yes AB 020998 UPJOHN
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204197 APOTEX INC
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 208701 CADILA PHARMS LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 207446 CIPLA
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 210071 CSPC OUYI
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 202240 LUPIN LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204590 MACLEODS PHARMS LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204776 MICRO LABS
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 078857 MYLAN
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 205129 SCIEGEN PHARMS INC
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 207872 TIANJIN TIANYAO
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 210628 UMEDICA LABS PVT LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 213301 UNICHEM
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 211412 YILING
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