Documents
Application Sponsors
| NDA 020938 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 7.5MG | 1 | MOBIC | MELOXICAM |
| 002 | TABLET;ORAL | 15MG | 1 | MOBIC | MELOXICAM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2000-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-11-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-12-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2004-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-01-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2003-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-11-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-12-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2005-08-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 2005-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2007-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2008-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2010-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2010-07-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2011-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2012-03-05 | UNKNOWN |
| LABELING; Labeling | SUPPL | 24 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2016-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 25 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 31 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 28 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 20938
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088646.pdf"]
[products] => [{"drugName":"MOBIC","activeIngredients":"MELOXICAM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MOBIC","activeIngredients":"MELOXICAM","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/30\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020938s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020938s024s025,021530s014s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020938s024s025,021530s014s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020938s024s025,021530s014s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020938s024s025,021530s014s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2012","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020938s022lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2011","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020938s021,021530s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2010","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020938s020,021530s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020938s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2008","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020938s018,021530s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020938s017,021530s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020938s013,015,021530s001,003lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2005","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020938s013,015,021530s001,003lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2004","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20938s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2003","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020938s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20938lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MOBIC","submission":"MELOXICAM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MOBIC","submission":"MELOXICAM","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-06-30
)
)