Application Sponsors
Marketing Status
Application Products
001 | AEROSOL, METERED;INHALATION | 0.36MG/INH | 0 | MEDIHALER ERGOTAMINE | ERGOTAMINE TARTRATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1960-01-13 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 1979-06-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-03-10 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
3M
cder:Array
(
[0] => Array
(
[ApplNo] => 12102
[companyName] => 3M
[docInserts] => ["",""]
[products] => [{"drugName":"MEDIHALER ERGOTAMINE","activeIngredients":"ERGOTAMINE TARTRATE","strength":"0.36MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MEDIHALER ERGOTAMINE","submission":"ERGOTAMINE TARTRATE","actionType":"0.36MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)