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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220675
Company: ASCENT PHARMS INC

Products on ANDA 220675

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220675

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	216399	AIPING PHARM INC
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	220675	ASCENT PHARMS INC
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	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	216399	AIPING PHARM INC
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	220675	ASCENT PHARMS INC
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	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

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