Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 50MG | 0 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-05-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-03-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-03-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-05-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-02-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-04-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-06-09 | |
LABELING; Labeling | SUPPL | 8 | AP | 1988-03-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-07-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-05-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-07-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-04-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-06-08 | |
LABELING; Labeling | SUPPL | 14 | AP | 2001-10-11 | |
LABELING; Labeling | SUPPL | 34 | AP | 2015-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2014-09-11 | |
LABELING; Labeling | SUPPL | 38 | AP | 2013-01-29 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 34 | Null | 7 |
SUPPL | 37 | Null | 15 |
SUPPL | 38 | Null | 15 |
TE Codes
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 88468
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)