Application Sponsors
ANDA 215697 | MANKIND PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 1MG BASE | 0 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE |
002 | CAPSULE;ORAL | EQ 2MG BASE | 0 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE |
003 | CAPSULE;ORAL | EQ 5MG BASE | 0 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-12-30 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
MANKIND PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 215697
[companyName] => MANKIND PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PRAZOSIN HYDROCHLORIDE","submission":"PRAZOSIN HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAZOSIN HYDROCHLORIDE","submission":"PRAZOSIN HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAZOSIN HYDROCHLORIDE","submission":"PRAZOSIN HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)