Application Sponsors
| ANDA 087689 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | CHLORTHALIDONE | CHLORTHALIDONE |
FDA Submissions
| ORIG | 1 | AP | 1981-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1984-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1984-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-04-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1985-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-05-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1986-05-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-05-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1988-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1988-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1990-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1991-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1991-01-28 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1994-03-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1994-09-14 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 22 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 87689
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)