Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021449
Company: GILEAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPSERA ADEFOVIR DIPIVOXIL 10MG 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
09/20/2002 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21449lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21449ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-449_Hepsera.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2018 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021449s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021449Orig1s024ltr.pdf
02/20/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/04/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/29/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021449Orig1s020ltr.pdf
02/29/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021449s018ltr.pdf
10/16/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021449s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021449s016ltr.pdf
05/27/2008 SUPPL-12 Labeling

Label is not available on this site.

12/19/2007 SUPPL-11 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021449s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021449s011ltr.pdf
09/20/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s009ltr.pdf
10/18/2006 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s006ltr.pdf
04/28/2006 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s005LTR.pdf
08/19/2004 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21449s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21449s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/28/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021449s024lbl.pdf
11/29/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s020lbl.pdf
02/29/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s018lbl.pdf
10/16/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021449s016lbl.pdf
12/19/2007 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021449s011lbl.pdf
10/18/2006 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s006lbl.pdf
09/20/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s009lbl.pdf
04/28/2006 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s005lbl.pdf
08/19/2004 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21449s003lbl.pdf
09/20/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21449lbl.pdf

HEPSERA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL 10MG TABLET;ORAL Prescription No AB 205459 APOTEX
ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL 10MG TABLET;ORAL Prescription No AB 202051 SIGMAPHARM LABS LLC
HEPSERA ADEFOVIR DIPIVOXIL 10MG TABLET;ORAL Prescription Yes AB 021449 GILEAD

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