Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 150MG | 0 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | 300MG | 0 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-06-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2018-11-05 | UNKNOWN |
Submissions Property Types
TE Codes
001 | Prescription | AB3 |
002 | Prescription | AB3 |
CDER Filings
ANBISON LAB
cder:Array
(
[0] => Array
(
[ApplNo] => 207224
[companyName] => ANBISON LAB
[docInserts] => ["",""]
[products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/05\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-05
)
)