Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017407
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CATAPRES CLONIDINE HYDROCHLORIDE 0.1MG TABLET;ORAL Prescription AB Yes No
CATAPRES CLONIDINE HYDROCHLORIDE 0.2MG TABLET;ORAL Prescription AB Yes No
CATAPRES CLONIDINE HYDROCHLORIDE 0.3MG TABLET;ORAL 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
09/03/1974 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/31/2012 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017407s037ltr.pdf
04/07/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s036ltr.pdf
11/09/2009 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017407s034ltr.pdf
01/05/2010 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s033ltr.pdf
04/13/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/30/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1996 SUPPL-28 Labeling

Label is not available on this site.

08/02/1996 SUPPL-27 Labeling

Label is not available on this site.

06/20/1988 SUPPL-26 Labeling

Label is not available on this site.

03/26/1987 SUPPL-25 Labeling

Label is not available on this site.

09/02/1987 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/11/1986 SUPPL-23 Labeling

Label is not available on this site.

10/02/1985 SUPPL-22 Labeling

Label is not available on this site.

03/06/1985 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1984 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/08/1987 SUPPL-19 Labeling

Label is not available on this site.

11/03/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/05/1981 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1981 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/20/1981 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/20/1981 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/1980 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1980 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/26/1980 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1980 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1978 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1979 SUPPL-8 Efficacy

Label is not available on this site.

02/05/1981 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1976 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1977 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1976 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/26/1976 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1976 SUPPL-1 Manufacturing (CMC)-Packaging

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-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf
04/07/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf
01/05/2010 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf
11/09/2009 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf

CATAPRES

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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