Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021530
Company: AVONDALE PHARMS
Company: AVONDALE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MELOXICAM | MELOXICAM | 7.5MG/5ML | SUSPENSION;ORAL | Prescription | None | Yes | Yes |
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-Medication Guide, Labeling-Package Insert, 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-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 | |
| 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 |