Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 5MG | 0 | METHYCLOTHIAZIDE | METHYCLOTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-02-12 | |
LABELING; Labeling | SUPPL | 4 | AP | 1988-05-13 | |
LABELING; Labeling | SUPPL | 5 | AP | 1988-12-14 | |
LABELING; Labeling | SUPPL | 6 | AP | 1992-01-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-04-01 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
CDER Filings
PAR PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 89136
[companyName] => PAR PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"METHYCLOTHIAZIDE","activeIngredients":"METHYCLOTHIAZIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHYCLOTHIAZIDE","submission":"METHYCLOTHIAZIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)