Documents
Application Sponsors
ANDA 077285 | WATSON LABS INC | |
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
| ORIG | 1 | AP | 2008-08-15 | |
LABELING; Labeling | SUPPL | 4 | AP | 2008-11-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2008-11-26 | |
LABELING; Labeling | SUPPL | 8 | AP | 2009-12-15 | |
REMS; REMS | SUPPL | 14 | AP | 2010-06-25 | |
LABELING; Labeling | SUPPL | 17 | AP | 2011-10-31 | |
LABELING; Labeling | SUPPL | 19 | AP | 2013-04-30 | STANDARD |
REMS; REMS | SUPPL | 20 | AP | 2013-03-11 | |
LABELING; Labeling | SUPPL | 30 | AP | 2015-02-25 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2015-02-25 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2017-06-12 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2020-10-07 | STANDARD |
Submissions Property Types
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 7 |
SUPPL | 17 | Null | 15 |
SUPPL | 19 | Null | 15 |
SUPPL | 20 | Null | 15 |
SUPPL | 30 | Null | 7 |
SUPPL | 32 | Null | 15 |
SUPPL | 34 | Null | 15 |
SUPPL | 35 | Null | 15 |
TE Codes
001 | Prescription | AB3 |
002 | Prescription | AB3 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77285
[companyName] => WATSON LABS INC
[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":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)