Application Sponsors
| ANDA 086055 | HIKMA INTL PHARMS | |
Marketing Status
Application Products
| 001 | TABLET;SUBLINGUAL | 5MG | 0 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE |
FDA Submissions
| ORIG | 1 | AP | 1987-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-03-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1986-05-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1984-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1987-01-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1987-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1987-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1988-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1993-06-16 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1993-06-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1993-06-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1993-06-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1991-02-13 | |
| LABELING; Labeling | SUPPL | 35 | AP | 1991-03-27 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1992-12-04 | |
| LABELING; Labeling | SUPPL | 37 | AP | 1994-03-02 | |
| LABELING; Labeling | SUPPL | 38 | AP | 1997-03-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1998-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2001-03-07 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2000-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2001-05-01 | |
| LABELING; Labeling | SUPPL | 43 | AP | 2002-07-01 | |
Submissions Property Types
| SUPPL | 9 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 42 | Null | 0 |
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 86055
[companyName] => HIKMA INTL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)