Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 1MG/5ML | 0 | IMODIUM | LOPERAMIDE HYDROCHLORIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1984-07-31 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-06-02 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1987-06-16 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 19037
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"IMODIUM","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"1MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IMODIUM","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"1MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)