Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020998
Company: GD SEARLE
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
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-Medication Guide, Labeling-Package Insert, 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
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 GD SEARLE
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
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 207446 CIPLA LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 207061 JUBILANT GENERICS
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 078857 MYLAN PHARMS INC
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 207677 TORRENT PHARMS LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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 GD SEARLE
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
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 207446 CIPLA LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 207061 JUBILANT GENERICS
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 078857 MYLAN PHARMS INC
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 207677 TORRENT PHARMS LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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 GD SEARLE
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207446 CIPLA LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207061 JUBILANT GENERICS
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 078857 MYLAN PHARMS INC
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207677 TORRENT PHARMS LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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 GD SEARLE
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
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 207446 CIPLA LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 207061 JUBILANT GENERICS
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 078857 MYLAN PHARMS INC
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 207677 TORRENT PHARMS LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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