Application Sponsors
ANDA 212613 | AMPHASTAR PHARMS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 250MCG/0.5ML | 0 | GANIRELIX ACETATE | GANIRELIX ACETATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-04-07 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AMPHASTAR PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212613
[companyName] => AMPHASTAR PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"GANIRELIX ACETATE","activeIngredients":"GANIRELIX ACETATE","strength":"250MCG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-04-07
)
)