Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | CARBAMAZEPINE | CARBAMAZEPINE |
FDA Submissions
| ORIG | 1 | AP | 1987-07-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-04-29 | |
LABELING; Labeling | SUPPL | 5 | AP | 1991-02-11 | |
LABELING; Labeling | SUPPL | 6 | AP | 1992-06-04 | |
LABELING; Labeling | SUPPL | 7 | AP | 1993-02-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-05-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-04-17 | |
LABELING; Labeling | SUPPL | 10 | AP | 1998-12-16 | |
LABELING; Labeling | SUPPL | 11 | AP | 2002-04-30 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 71479
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CARBAMAZEPINE","submission":"CARBAMAZEPINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)