Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020998
Company: UPJOHN
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 |
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 |