Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078895
Company: UNICHEM
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/26/2009 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-7 Labeling-Package Insert

Label is not available on this site.

09/23/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/15/2010 SUPPL-1 Labeling-Package Insert

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

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CATAPRES CLONIDINE HYDROCHLORIDE 0.2MG TABLET;ORAL Prescription Yes AB 017407 BOEHRINGER INGELHEIM
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 070923 FRONTIDA BIOPHARM
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 070317 MYLAN
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 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
CATAPRES CLONIDINE HYDROCHLORIDE 0.3MG TABLET;ORAL Prescription Yes AB 017407 BOEHRINGER INGELHEIM
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 070923 FRONTIDA BIOPHARM
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 070317 MYLAN
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 202297 YUNG SHIN PHARM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English