ANDA 201408

TWI PHARMS

FDA Drug Application

Application #201408

Documents

• Letter: 2015-06-04

Application Sponsors

ANDA 201408

TWI PHARMS

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-06-02
LABELING; Labeling	SUPPL	4	AP	2019-07-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-07-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-07-30	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	8	Null	15

TE Codes

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

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201408
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201408Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/30\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-30
        )

)