Application Sponsors
| ANDA 088974 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-07-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-07-25 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1989-04-06 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1991-08-09 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1991-11-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-08-02 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-06-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-04-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-03-22 | |
| LABELING; Labeling | SUPPL | 18 | AP | 2002-01-04 | |
| LABELING; Labeling | SUPPL | 19 | AP | 2002-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2003-01-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-12-09 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 1 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
CDER Filings
ANI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 88974
[companyName] => ANI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)