Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021004
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIVIR-HBV LAMIVUDINE 5MG/ML SOLUTION;ORAL Prescription None 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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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