Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200881
Company: ACTAVIS ELIZABETH

Products on ANDA 200881

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200881

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2012	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200881Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/04/2019	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/04/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/30/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/10/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 200881

GUANFACINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200881	ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205430	APOTEX
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202568	SANDOZ INC
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205689	SUN PHARM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201382	TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201408	TWI PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213428	YICHANG HUMANWELL
INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022037	TAKEDA PHARMS USA

TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200881	ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205430	APOTEX
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202568	SANDOZ INC
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205689	SUN PHARM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201382	TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201408	TWI PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213428	YICHANG HUMANWELL
INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022037	TAKEDA PHARMS USA

TABLET, EXTENDED RELEASE;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200881	ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205430	APOTEX
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202568	SANDOZ INC
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205689	SUN PHARM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201382	TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201408	TWI PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213428	YICHANG HUMANWELL
INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022037	TAKEDA PHARMS USA

TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200881	ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205430	APOTEX
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202568	SANDOZ INC
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205689	SUN PHARM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201382	TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201408	TWI PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213428	YICHANG HUMANWELL
INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022037	TAKEDA PHARMS USA