Application Sponsors
| ANDA 211020 | GRAVITI 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 | 2019-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-06-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2022-06-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-06-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 7 |
TE Codes
| 001 | Prescription | AB3 |
| 002 | Prescription | AB3 |
CDER Filings
ADAPTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 211020
[companyName] => ADAPTIS
[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":"01\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-30
)
)