Application Sponsors
| ANDA 206556 | INVAGEN PHARMS | |
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 | 2016-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-06-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 14 | Null | 15 |
TE Codes
| 001 | Prescription | AB3 |
| 002 | Prescription | AB3 |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 206556
[companyName] => INVAGEN PHARMS
[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":"08\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/12\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-30
)
)