Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079090
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONIDINE CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
CLONIDINE CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
CLONIDINE CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
08/20/2010 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
05/29/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

CLONIDINE

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CATAPRES-TTS-1 CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 018891 BOEHRINGER INGELHEIM
CLONIDINE CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 090873 ACTAVIS LABS UT INC
CLONIDINE CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076157 AVEVA
CLONIDINE CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 079090 MAYNE PHARMA
CLONIDINE CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076166 MYLAN TECHNOLOGIES

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.2MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CATAPRES-TTS-2 CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 018891 BOEHRINGER INGELHEIM
CLONIDINE CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 090873 ACTAVIS LABS UT INC
CLONIDINE CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076157 AVEVA
CLONIDINE CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 079090 MAYNE PHARMA
CLONIDINE CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076166 MYLAN TECHNOLOGIES

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.3MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CATAPRES-TTS-3 CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 018891 BOEHRINGER INGELHEIM
CLONIDINE CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 090873 ACTAVIS LABS UT INC
CLONIDINE CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076157 AVEVA
CLONIDINE CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 079090 MAYNE PHARMA
CLONIDINE CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 076166 MYLAN TECHNOLOGIES

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