An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070886
Company: AUROBINDO PHARMA LTD

Products on ANDA 070886

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.2MG	TABLET;ORAL	Prescription	AB	No	No
CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	0.1MG	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 070886

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1988	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
03/02/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/25/1998	SUPPL-5	Labeling		Label is not available on this site.
02/01/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/04/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070886

CLONIDINE HYDROCHLORIDE

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; 0.1MG
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; 0.3MG
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

Top