Application Sponsors
ANDA 088959 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-12-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-02-26 | |
LABELING; Labeling | SUPPL | 6 | AP | 1989-02-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-05-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-01-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1992-12-22 | |
LABELING; Labeling | SUPPL | 10 | AP | 1992-03-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1992-12-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-05-11 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 88959
[companyName] => ANI PHARMS INC
[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
)
)