Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 30MG | 0 | FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-12-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-10-21 | |
LABELING; Labeling | SUPPL | 3 | AP | 1988-10-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-08-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-08-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-03-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-03-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-03-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-03-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-04-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-04-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1988-07-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-08-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1989-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1989-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1989-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1991-01-31 | |
LABELING; Labeling | SUPPL | 20 | AP | 1994-05-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1998-10-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-10-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-11-30 | |
LABELING; Labeling | SUPPL | 25 | AP | 2008-08-20 | |
LABELING; Labeling | SUPPL | 26 | AP | 2009-08-11 | |
LABELING; Labeling | SUPPL | 27 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2016-11-18 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2019-02-22 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2021-02-08 | STANDARD |
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 | 11 | 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 | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 26 | Null | 7 |
SUPPL | 27 | Null | 7 |
SUPPL | 28 | Null | 7 |
SUPPL | 29 | Null | 7 |
SUPPL | 30 | Null | 15 |
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 71108
[companyName] => HIKMA
[docInserts] => ["",""]
[products] => [{"drugName":"FLURAZEPAM HYDROCHLORIDE","activeIngredients":"FLURAZEPAM HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLURAZEPAM HYDROCHLORIDE","submission":"FLURAZEPAM HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)