Documents
Application Sponsors
| NDA 213591 | NOVARTIS PHARMS CORP | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 150MG | 2 | TABRECTA | CAPMATINIB HYDROCHLORIDE |
| 002 | TABLET;ORAL | 200MG | 2 | TABRECTA | CAPMATINIB HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-05-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2022-01-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2022-08-10 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Orphan | 5 |
| SUPPL | 4 | Null | 7 |
CDER Filings
NOVARTIS PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 213591
[companyName] => NOVARTIS PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"TABRECTA","activeIngredients":"CAPMATINIB HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TABRECTA","activeIngredients":"CAPMATINIB HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213591s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213591s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213591Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213591Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-05-06
)
)