Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210338
Company: JUBILANT GENERICS

Products on ANDA 210338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210338

CLONIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 0.1MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	203320	ACTAVIS ELIZABETH
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209686	AJANTA PHARMA LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209285	CHARTWELL RX
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	210338	JUBILANT GENERICS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209675	NOVAST LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	209757	XIAMEN LP PHARM CO