ANDA 211920

GLAND PHARMA LTD

FDA Drug Application

Application #211920

Application Sponsors

ANDA 211920

GLAND PHARMA LTD

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	50MG/5ML (10MG/ML)	0	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	100MG/10ML (10MG/ML)	0	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE
003	SOLUTION;INTRAVENOUS	10MG/ML (10MG/ML)	0	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP1
002	Prescription	AP1
003	Prescription	AP1

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211920
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-05
        )

)