ANDA 216399

TWI PHARMS

FDA Drug Application

Application #216399

Application Sponsors

ANDA 216399

TWI PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 2MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216399
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-08
        )

)