Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018891
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CATAPRES-TTS-1 CLONIDINE 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
CATAPRES-TTS-2 CLONIDINE 0.2MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
CATAPRES-TTS-3 CLONIDINE 0.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/10/1984 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018891s028ltr.pdf
04/28/2010 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018891s027ltr.pdf
11/13/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018891s025ltr.pdf
04/13/2006 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018891s024ltr.pdf
08/13/2004 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18891s022ltr.pdf
08/30/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/23/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1996 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1996 SUPPL-16 Labeling

Label is not available on this site.

09/06/1996 SUPPL-15 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.cfm
02/19/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/24/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/13/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/09/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/18/1989 SUPPL-9 Labeling

Label is not available on this site.

12/07/1988 SUPPL-8 Labeling

Label is not available on this site.

10/27/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1988 SUPPL-4 Labeling

Label is not available on this site.

05/11/1988 SUPPL-3 Labeling

Label is not available on this site.

09/18/1985 SUPPL-2 Labeling

Label is not available on this site.

04/18/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf
04/28/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf
11/13/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf

CATAPRES-TTS-1

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

CATAPRES-TTS-2

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

CATAPRES-TTS-3

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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