Application Sponsors
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 150MG | 0 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2020-11-30 | |
LABELING; Labeling | SUPPL | 2 | AP | 2022-12-13 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 200216
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-11-30
)
)