Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017473
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORAP PIMOZIDE 2MG TABLET;ORAL Prescription AB Yes Yes
ORAP PIMOZIDE 1MG TABLET;ORAL Prescription AB Yes 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
07/31/1984 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/11/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

01/26/2015 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

08/01/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

09/27/2011 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017473s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017473s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/017473Orig1s046.pdf
12/01/2010 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017473s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017473s045ltr.pdf
07/19/2009 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s043ltr.pdf
04/28/2009 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017473s041ltr.pdf
10/27/2003 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17473slr039ltr.pdf
11/14/2002 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17473slr038ltr.pdf
11/09/1999 SUPPL-36 Labeling

Label is not available on this site.

11/12/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/23/2000 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1999 SUPPL-33 Labeling

Label is not available on this site.

05/20/1998 SUPPL-32 Labeling

Label is not available on this site.

03/23/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/27/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1997 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/12/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/27/1994 SUPPL-16 Labeling

Label is not available on this site.

07/27/1994 SUPPL-15 Efficacy-New Patient Population

Label is not available on this site.

02/12/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/16/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1990 SUPPL-12 Labeling

Label is not available on this site.

10/27/1988 SUPPL-11 Labeling

Label is not available on this site.

11/29/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1987 SUPPL-9 Labeling

Label is not available on this site.

09/17/1986 SUPPL-8 Labeling

Label is not available on this site.

04/20/1987 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/15/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1985 SUPPL-4 Labeling

Label is not available on this site.

03/11/1985 SUPPL-2 Labeling

Label is not available on this site.

11/14/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2011 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017473s046lbl.pdf
12/01/2010 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017473s045lbl.pdf
07/19/2009 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s043lbl.pdf
04/28/2009 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017473s041lbl.pdf

ORAP

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAP PIMOZIDE 2MG TABLET;ORAL Prescription Yes AB 017473 TEVA
PIMOZIDE PIMOZIDE 2MG TABLET;ORAL Prescription No AB 204521 PAR PHARM

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAP PIMOZIDE 1MG TABLET;ORAL Prescription Yes AB 017473 TEVA
PIMOZIDE PIMOZIDE 1MG TABLET;ORAL Prescription No AB 204521 PAR PHARM

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