Application Sponsors
| ANDA 088877 | LANNETT CO INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE |
FDA Submissions
| ORIG | 1 | AP | 1985-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-12-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-12-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-12-29 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1991-06-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-05-27 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1991-08-28 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1993-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-07-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1997-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-07-02 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1998-02-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-11-30 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2002-05-28 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 88877
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)