Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 150MG/ML | 0 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-05-01 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-06-22 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2021-06-22 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 8 | Null | 15 |
TE Codes
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 210760
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"MEDROXYPROGESTERONE ACETATE","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-05-01
)
)