ANDA 214031

ALEMBIC PHARMS LTD

FDA Drug Application

Application #214031

Application Sponsors

ANDA 214031

ALEMBIC PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE
002	TABLET;ORAL	5MG	0	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE
003	TABLET;ORAL	10MG	0	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE
004	TABLET;ORAL	20MG	0	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214031
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-04
        )

)