Application Sponsors
ANDA 072163 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 50MG | 0 | MAPROTILINE HYDROCHLORIDE | MAPROTILINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1988-06-01 | |
LABELING; Labeling | SUPPL | 2 | AP | 1990-11-29 | |
LABELING; Labeling | SUPPL | 3 | AP | 1992-05-20 | |
LABELING; Labeling | SUPPL | 4 | AP | 1992-06-04 | |
LABELING; Labeling | SUPPL | 5 | AP | 1998-08-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-11-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-11-07 | |
LABELING; Labeling | SUPPL | 9 | AP | 2014-07-17 | STANDARD |
Submissions Property Types
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 15 |
CDER Filings
HERITAGE PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 72163
[companyName] => HERITAGE PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"MAPROTILINE HYDROCHLORIDE","activeIngredients":"MAPROTILINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MAPROTILINE HYDROCHLORIDE","submission":"MAPROTILINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)