Application Sponsors
ANDA 210148 | ACCORD HLTHCARE INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 6MG/ML | 0 | BUSULFAN | BUSULFAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-02-22 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-03-10 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACCORD HLTHCARE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210148
[companyName] => ACCORD HLTHCARE INC
[docInserts] => ["",""]
[products] => [{"drugName":"BUSULFAN","activeIngredients":"BUSULFAN","strength":"6MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-22
)
)