Application Sponsors
| ANDA 080212 | HIKMA INTL PHARMS | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 100MG | 0 | ISONIAZID | ISONIAZID |
FDA Submissions
| ORIG | 1 | AP | 1972-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1991-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-10-23 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1995-06-23 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1995-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1995-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-06-23 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1997-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1997-08-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1997-08-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1998-10-01 | |
| LABELING; Labeling | SUPPL | 37 | AP | 2008-10-31 | |
Submissions Property Types
| SUPPL | 6 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 80212
[companyName] => HIKMA INTL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ISONIAZID","activeIngredients":"ISONIAZID","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ISONIAZID","submission":"ISONIAZID","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)