Application Sponsors
| ANDA 089456 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 8MG | 0 | PERPHENAZINE | PERPHENAZINE |
FDA Submissions
| ORIG | 1 | AP | 1987-09-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-02-23 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1990-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-04-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1993-03-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-06-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-12-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-09-20 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2002-09-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-07-29 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2017-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2017-02-23 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 7 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89456
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PERPHENAZINE","submission":"PERPHENAZINE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)