Application Sponsors
| ANDA 086028 | HIKMA INTL PHARMS | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 250MG | 0 | CHLOROTHIAZIDE | CHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 1982-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1991-04-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1991-04-16 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1992-07-29 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1990-05-04 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1995-05-24 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1996-09-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1998-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2001-06-14 | |
Submissions Property Types
| SUPPL | 1 | 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 | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 86028
[companyName] => HIKMA INTL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"CHLOROTHIAZIDE","activeIngredients":"CHLOROTHIAZIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLOROTHIAZIDE","submission":"CHLOROTHIAZIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)