Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021530
Company: AVONDALE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOBIC MELOXICAM 7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None Yes No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
06/01/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21530_mobic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21530ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021530s000_MobicTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021530s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021530Orig1s017ltr.pdf
09/01/2016 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021530s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021530Orig1s016ltr.pdf
05/09/2016 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf
05/09/2016 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf
08/12/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/05/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021530s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011ltr.pdf
08/03/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009ltr.pdf
07/29/2010 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008ltr.pdf
04/26/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021530s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007ltr.pdf
06/27/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018, 021530s006ltr.pdf
01/25/2007 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017, 021530s005ltr.pdf
08/11/2005 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf
08/11/2005 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2021 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021530s017lbl.pdf
09/01/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021530s016lbl.pdf
05/09/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
05/09/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
05/09/2016 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
05/09/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
03/05/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021530s011lbl.pdf
08/03/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf
07/29/2010 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf
04/26/2010 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021530s007lbl.pdf
06/27/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf
01/25/2007 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf
08/11/2005 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf
08/11/2005 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf
06/01/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21530_mobic_lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English