Application Sponsors
| ANDA 085003 | HIKMA INTL PHARMS | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | AMINOPHYLLINE | AMINOPHYLLINE |
FDA Submissions
| ORIG | 1 | AP | 1976-05-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1982-12-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1983-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1984-02-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1984-03-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1985-03-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1986-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1986-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1989-01-27 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1989-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1989-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1991-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1991-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1991-04-02 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1991-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1991-04-02 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1990-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1994-06-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1995-05-26 | |
| LABELING; Labeling | SUPPL | 37 | AP | 1996-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1998-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2000-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2000-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2000-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2002-07-03 | |
Submissions Property Types
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 85003
[companyName] => HIKMA INTL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOPHYLLINE","activeIngredients":"AMINOPHYLLINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINOPHYLLINE","submission":"AMINOPHYLLINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)