Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020998
Company: UPJOHN

• Medication Guide

• Other Important Information from FDA

Products on NDA 20998

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

Labels for NDA 020998

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