GRANULES FDA Approval ANDA 214608

ANDA 214608

GRANULES

FDA Drug Application

Application #214608

Application Sponsors

ANDA 214608GRANULES

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 1MG BASE0PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDE
002CAPSULE;ORALEQ 2MG BASE0PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDE
003CAPSULE;ORALEQ 5MG BASE0PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

GRANULES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214608
            [companyName] => GRANULES
            [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
        )

)

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