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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021449
Company: GILEAD

Products on NDA 021449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPSERA	ADEFOVIR DIPIVOXIL	10MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021449

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

Labels for NDA 021449

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

Therapeutic Equivalents for NDA 021449

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

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