Application Sponsors
NDA 018102 | PHARMACIA AND UPJOHN | |
Marketing Status
Application Products
001 | ENEMA;RECTAL | 40MG/BOT | 0 | MEDROL | METHYLPREDNISOLONE ACETATE |
FDA Submissions
TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1977-12-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1981-04-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-11-19 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 4 | Null | 0 |
CDER Filings
PHARMACIA AND UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 18102
[companyName] => PHARMACIA AND UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"MEDROL","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"40MG\/BOT","dosageForm":"ENEMA;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MEDROL","submission":"METHYLPREDNISOLONE ACETATE","actionType":"40MG\/BOT","submissionClassification":"ENEMA;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)