ANDA 213441

ZYDUS

FDA Drug Application

Application #213441

Application Sponsors

ANDA 213441

ZYDUS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	EQ 10MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
002	CAPSULE;ORAL		0	0	NORTRIPTYLINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 50MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 75MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

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
        )

)