Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021200
Company: US WORLDMEDS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZELNORM TEGASEROD MALEATE EQ 2MG BASE TABLET;ORAL Discontinued None No No
ZELNORM TEGASEROD MALEATE EQ 6MG BASE TABLET;ORAL Discontinued None 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
07/24/2002 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21200ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-200_Zelnorm.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021200s014ltr.pdf
06/02/2006 SUPPL-12 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021200s012LTR.pdf
05/25/2005 SUPPL-10 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021200s010ltr.pdf
04/15/2004 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021200s009ltr.pdf
04/21/2004 SUPPL-8 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf
04/21/2004 SUPPL-7 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf
06/15/2004 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scm006ltr.pdf
08/21/2004 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/01/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf
08/21/2004 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf
06/15/2004 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf
04/21/2004 SUPPL-8 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf
04/21/2004 SUPPL-7 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf
04/15/2004 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf
07/24/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English