Application Sponsors
ANDA 089219 | ANI PHARMS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | CAPSULE;ORAL | 250MG | 0 | PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE |
002 | CAPSULE;ORAL | 375MG | 0 | PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE |
003 | CAPSULE;ORAL | 500MG | 0 | PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-07-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-07-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-07-14 | |
LABELING; Labeling | SUPPL | 4 | AP | 1988-10-20 | |
LABELING; Labeling | SUPPL | 5 | AP | 1991-02-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1994-01-24 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89219
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"375MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"375MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)