Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070974
Company: ACTAVIS ELIZABETH
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/16/1986 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
01/16/2013 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

06/23/2010 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

08/08/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

02/18/1997 SUPPL-12 Labeling

Label is not available on this site.

01/18/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/04/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-8 Labeling

Label is not available on this site.

11/21/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-6 Labeling

Label is not available on this site.

11/17/1988 SUPPL-5 Labeling

Label is not available on this site.

01/28/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/09/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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
CATAPRES CLONIDINE HYDROCHLORIDE 0.1MG TABLET;ORAL Prescription Yes AB 017407 BOEHRINGER INGELHEIM
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 070923 FRONTIDA BIOPHARM
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 070317 MYLAN
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 202297 YUNG SHIN PHARM

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