Drugs@FDA: FDA Approved Drug Products

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

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

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