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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203320
Company: ACTAVIS ELIZABETH

Products on ANDA 203320

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
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203320

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2015	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
05/27/2020	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/27/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/13/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/13/2015	SUPPL-1	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 203320

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

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