ANDA 086032 | ANI PHARMS INC |
Discontinued | 001 |
001 | TABLET;ORAL | 10MG | 0 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE |
ORIG | 1 | AP | 1988-01-07 | ||
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1982-07-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1985-02-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1985-06-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1988-03-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-03-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-03-29 | |
LABELING; Labeling | SUPPL | 26 | AP | 1988-06-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1990-06-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1991-08-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1990-11-19 | |
LABELING; Labeling | SUPPL | 30 | AP | 1991-09-12 | |
LABELING; Labeling | SUPPL | 31 | AP | 1991-12-19 | |
LABELING; Labeling | SUPPL | 32 | AP | 1992-04-02 | |
LABELING; Labeling | SUPPL | 33 | AP | 1992-11-16 | |
LABELING; Labeling | SUPPL | 34 | AP | 1996-12-10 |
SUPPL | 13 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
cder:Array ( [0] => Array ( [ApplNo] => 86032 [companyName] => ANI PHARMS INC [docInserts] => ["",""] [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}] [labels] => [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}] [supplements] => [actionDate] => 1969-12-31 ) )