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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091368
Company: ALEMBIC PHARMS LTD

Products on ANDA 091368

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	AB	No	No
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	AB	No	No
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2011	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
01/17/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091368

CLONIDINE HYDROCHLORIDE

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	070974	ACTAVIS ELIZABETH
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	091368	ALEMBIC PHARMS LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	070886	AUROBINDO PHARMA LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	071785	CHARTWELL MOLECULES
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	078099	IMPAX LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	077901	PRINSTON INC
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	078895	UNICHEM
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	070923	URL LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	202297	YUNG SHIN PHARM

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	070975	ACTAVIS ELIZABETH
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	091368	ALEMBIC PHARMS LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	070886	AUROBINDO PHARMA LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	071785	CHARTWELL MOLECULES
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	078099	IMPAX LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	077901	PRINSTON INC
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	078895	UNICHEM
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	070923	URL LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	202297	YUNG SHIN PHARM

TABLET;ORAL; 0.3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	070976	ACTAVIS ELIZABETH
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	091368	ALEMBIC PHARMS LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	070886	AUROBINDO PHARMA LTD
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	071785	CHARTWELL MOLECULES
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	078099	IMPAX LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	077901	PRINSTON INC
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	078895	UNICHEM
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	070923	URL LABS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	202297	YUNG SHIN PHARM

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