ANDA 210826

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210826

Application Sponsors

ANDA 210826

AUROBINDO PHARMA LTD

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 20MG BASE	0	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 40MG BASE	0	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 80MG BASE	0	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	EQ 120MG BASE	0	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210826
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 80MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 120MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-06
        )

)