ZYDUS FDA Approval ANDA 213441

ANDA 213441

ZYDUS

FDA Drug Application

Application #213441

Application Sponsors

ANDA 213441ZYDUS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORALEQ 10MG BASE0NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDE
002CAPSULE;ORAL00NORTRIPTYLINE HYDROCHLORIDE
003CAPSULE;ORALEQ 50MG BASE0NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDE
004CAPSULE;ORALEQ 75MG BASE0NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213441
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/24\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-24
        )

)

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