Drugs@FDA: FDA Approved Drug Products

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