Documents
Application Sponsors
NDA 214121 | ACCORD HLTHCARE INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5G/50ML | 0 | METHOTREXATE | METHOTREXATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-08-24 | STANDARD |
Submissions Property Types
CDER Filings
ACCORD HLTHCARE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 214121
[companyName] => ACCORD HLTHCARE INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHOTREXATE","activeIngredients":"METHOTREXATE","strength":"5G\/50ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214121Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-08-24
)
)