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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021004
Company: GLAXOSMITHKLINE

Products on NDA 021004

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPIVIR-HBV	LAMIVUDINE	5MG/ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/1998	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2021	SUPPL-23	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021003_021004_S023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021003Orig1s023, 021004Orig1s023ltr.pdf
11/15/2018	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021004s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021003Orig1s020,021004Orig1s020ltr.pdf
09/27/2017	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s017,021004s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021003Orig1s017,021004Orig1s017ltr.pdf
05/08/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s016,021004s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021003Orig1s016,021004Orig1s016ltr.pdf
12/20/2013	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004Orig1s015ltr.pdf
01/21/2011	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013ltr.pdf
09/26/2007	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021003s010,021004s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010, 021004s010ltr.pdf
09/27/2004	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s006,21004s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s006,21004s007ltr.pdf
11/22/2004	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s005,21004s006ltr.pdf
11/13/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21003slr004,21004slr005_epivir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr005ltr.pdf
12/24/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/13/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/16/2001	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21004s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-003SE1002_EpivirHBV.cfm
03/31/2000	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021004

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2021	SUPPL-23	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021003_021004_S023lbl.pdf
12/22/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021003_021004_S023lbl.pdf
11/15/2018	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021004s020lbl.pdf
09/27/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s017,021004s017lbl.pdf
09/27/2017	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s017,021004s017lbl.pdf
05/08/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021003s016,021004s016lbl.pdf
12/20/2013	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.pdf
01/21/2011	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.pdf
09/26/2007	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021003s010,021004s010lbl.pdf
11/22/2004	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf
09/27/2004	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s006,21004s007lbl.pdf
11/13/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21003slr004,21004slr005_epivir_lbl.pdf
08/16/2001	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21004s2lbl.pdf
12/08/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_prntlbl.pdf

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