ANDA 216809

GLAND PHARMA LTD

FDA Drug Application

Application #216809

Application Sponsors

ANDA 216809

GLAND PHARMA LTD

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 10MG BASE/ML	0	0	KETAMINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 50MG BASE/ML	0	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 100MG BASE/ML	0	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216809
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETAMINE HYDROCHLORIDE","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETAMINE HYDROCHLORIDE","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETAMINE HYDROCHLORIDE","activeIngredients":"KETAMINE HYDROCHLORIDE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-24
        )

)