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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071785
Company: CHARTWELL MOLECULES

Products on ANDA 071785

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/1988	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
06/08/2017	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/05/2006	SUPPL-13	Labeling		Label is not available on this site.
09/18/2000	SUPPL-11	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/18/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/18/1997	SUPPL-9	Labeling		Label is not available on this site.
11/13/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/26/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/03/1990	SUPPL-6	Labeling		Label is not available on this site.
10/18/1989	SUPPL-5	Labeling		Label is not available on this site.
05/12/1988	SUPPL-2	Labeling		Label is not available on this site.
05/12/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071785

CLONIDINE HYDROCHLORIDE

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	070923	TP ANDA HOLDINGS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	078895	UNICHEM
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.3MG	TABLET;ORAL	Prescription	No	AB	202297	YUNG SHIN PHARM

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	070923	TP ANDA HOLDINGS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET;ORAL	Prescription	No	AB	078895	UNICHEM
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	070923	TP ANDA HOLDINGS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	078895	UNICHEM
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	No	AB	202297	YUNG SHIN PHARM

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