Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1.5MG/ML | 0 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1993-03-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-10-31 | STANDARD |
Submissions Property Types
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 20200
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"NALBUPHINE HYDROCHLORIDE","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"1.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NALBUPHINE HYDROCHLORIDE","submission":"NALBUPHINE HYDROCHLORIDE","actionType":"1.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)