Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 200MG | 1 | CARBAGLU | CARGLUMIC ACID |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2010-03-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-08-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-01-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-11-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-11-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2021-01-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2021-01-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-08-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Orphan | 5 |
TE Codes
CDER Filings
RECORDATI RARE
cder:Array
(
[0] => Array
(
[ApplNo] => 22562
[companyName] => RECORDATI RARE
[docInserts] => ["",""]
[products] => [{"drugName":"CARBAGLU","activeIngredients":"CARGLUMIC ACID","strength":"200MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/23\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022562s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022562s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022562s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022562lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CARBAGLU","submission":"CARGLUMIC ACID","actionType":"200MG","submissionClassification":"TABLET, FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-12-23
)
)