APPCO FDA Approval ANDA 213406

ANDA 213406

APPCO

FDA Drug Application

Application #213406

Application Sponsors

ANDA 213406APPCO

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; ORIG1AP2022-10-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

APPCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213406
            [companyName] => APPCO
            [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":"10\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-21
        )

)

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