Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | PYRAZINAMIDE | PYRAZINAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1992-06-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-02-28 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1994-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-02-28 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1994-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-09-16 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1994-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1996-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-05-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-05-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-08-13 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
TE Codes
CDER Filings
AKORN
cder:Array
(
[0] => Array
(
[ApplNo] => 81319
[companyName] => AKORN
[docInserts] => ["",""]
[products] => [{"drugName":"PYRAZINAMIDE","activeIngredients":"PYRAZINAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PYRAZINAMIDE","submission":"PYRAZINAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)