Documents
Application Sponsors
NDA 212035 | ACCORD HLTHCARE INC | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | INJECTABLE;INJECTION | 50MG/50ML (1MG/ML) | 2 | ARGATROBAN | ARGATROBAN |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | TA | 2019-02-28 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACCORD HLTHCARE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212035
[companyName] => ACCORD HLTHCARE INC
[docInserts] => ["",""]
[products] => [{"drugName":"ARGATROBAN","activeIngredients":"ARGATROBAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/28\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212035Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-28
)
)