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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021156
Company: GD SEARLE LLC

Medication Guide

Other Important Information from FDA

Products on NDA 021156

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CELEBREX	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	None	No	No
CELEBREX	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	None	No	No
CELEBREX	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021156

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1999	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2011	SUPPL-3	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
08/29/2002	SUPPL-2	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21156scf001scp002ltr.pdf
08/29/2002	SUPPL-1	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21156scf001scp002ltr.pdf

Labels for NDA 021156

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2011	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf
12/23/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf

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