UNICHEM FDA Approval ANDA 214548

ANDA 214548

UNICHEM

FDA Drug Application

Application #214548

Application Sponsors

ANDA 214548UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL10MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
002TABLET;ORAL25MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
003TABLET;ORAL50MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
004TABLET;ORAL75MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
005TABLET;ORAL100MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
006TABLET;ORAL150MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214548
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-19
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.