Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE |
002 | TABLET;ORAL | 50MG | 0 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 2008-08-15 | |
LABELING; Labeling | SUPPL | 4 | AP | 2011-11-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2016-03-07 | UNKNOWN |
LABELING; Labeling | SUPPL | 18 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
SUPPL | 4 | Null | 15 |
SUPPL | 9 | Null | 7 |
SUPPL | 18 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
UNICHEM
cder:Array
(
[0] => Array
(
[ApplNo] => 40907
[companyName] => UNICHEM
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)