Application Sponsors
ANDA 088164 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 25MG | 0 | CHLORTHALIDONE | CHLORTHALIDONE |
FDA Submissions
| ORIG | 1 | AP | 1984-01-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1984-04-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1984-04-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1984-09-17 | |
LABELING; Labeling | SUPPL | 8 | AP | 1993-03-08 | |
LABELING; Labeling | SUPPL | 9 | AP | 1995-01-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-04-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-04-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-04-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-01-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2002-07-29 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 88164
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)