Application Sponsors
ANDA 214297 | PAR STERILE PRODUCTS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 40MG/ML | 0 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE |
002 | INJECTABLE;INJECTION | 80MG/ML | 0 | METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-01-21 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 214297
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-01-21
)
)