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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203167
Company: XGEN PHARMS

Products on ANDA 203167

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203167

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2013	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203167

CLONIDINE HYDROCHLORIDE

INJECTABLE;INJECTION; 1MG/10ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200673	FRESENIUS KABI USA
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200300	HIKMA FARMACEUTICA
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203167	XGEN PHARMS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202601	ZYDUS PHARMS
DURACLON	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	020615	MYLAN INSTITUTIONAL

INJECTABLE;INJECTION; 5MG/10ML (0.5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200673	FRESENIUS KABI USA
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200300	HIKMA FARMACEUTICA
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203167	XGEN PHARMS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202601	ZYDUS PHARMS

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