Application Sponsors
ANDA 215587 | MANKIND PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | CHLORTHALIDONE | CHLORTHALIDONE |
002 | TABLET;ORAL | 50MG | 0 | CHLORTHALIDONE | CHLORTHALIDONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-08-04 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
MANKIND PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 215587
[companyName] => MANKIND PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)