Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075109
Company: AMNEAL PHARM

Products on ANDA 075109

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/1998	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/04/2002	SUPPL-3	Labeling		Label is not available on this site.
06/22/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075109

GUANFACINE HYDROCHLORIDE

TABLET;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;ORAL	Prescription	No	AB	217293	AJANTA PHARMA LTD
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	075109	AMNEAL PHARM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	074796	AUROBINDO PHARMA USA
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	074673	EPIC PHARMA LLC
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	216828	I 3 PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	216762	RUBICON
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	216399	TWI PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	214689	UNICHEM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	074145	WATSON LABS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218326	XIROMED

TABLET;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;ORAL	Prescription	No	AB	217293	AJANTA PHARMA LTD
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	075109	AMNEAL PHARM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	074796	AUROBINDO PHARMA USA
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	074673	EPIC PHARMA LLC
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	216828	I 3 PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	216762	RUBICON
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	216399	TWI PHARMS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	214689	UNICHEM
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	074145	WATSON LABS
GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218326	XIROMED