ANDA 214548

UNICHEM

FDA Drug Application

Application #214548

Application Sponsors

ANDA 214548

UNICHEM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	10MG	0	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE
004	TABLET;ORAL	75MG	0	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE
005	TABLET;ORAL	100MG	0	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE
006	TABLET;ORAL	150MG	0	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

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
        )

)