Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020596
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIVIR LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription AA 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
11/17/1995 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/2019 SUPPL-38 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020564Orig1s039, 020596Orig1s038ltr.pdf
04/27/2018 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020564Orig1s038,020596Orig1s037ltr.pdf
09/25/2017 SUPPL-36 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf
07/20/2016 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020564Orig1s036,020596Orig1s035ltr.pdf
09/30/2015 SUPPL-34 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596Orig1s034ltr.pdf
02/19/2015 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s034,020596Orig1s033ltr.pdf
03/23/2015 SUPPL-32 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s033,020596Orig1s032ltr.pdf
11/18/2011 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030ltr.pdf
10/25/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s027.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s027ltr.pdf
06/13/2006 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025, 020564s024LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020596_S025_Epivir.pdf
09/29/2004 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr.pdf
11/22/2004 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s021,20564s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020596_S021_Epivir.pdf
11/13/2003 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20596slr020,20564slr019ltr.pdf
12/24/2002 SUPPL-19 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020596_S019_Epivir.pdf
09/13/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/01/2002 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s16ltr.pdf
06/24/2002 SUPPL-16 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s016ltr.pdf
10/08/2002 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564slr014,20596slr015ltr.pdf
06/19/2001 SUPPL-14 Labeling

Label is not available on this site.

03/06/2001 SUPPL-13 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-596s013_Epivir.cfm
01/05/2001 SUPPL-12 Labeling

Label is not available on this site.

10/08/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/18/1999 SUPPL-10 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S010_Epivir.pdf
03/08/1999 SUPPL-9 Labeling

Label is not available on this site.

03/08/1999 SUPPL-8 Labeling

Label is not available on this site.

03/23/1999 SUPPL-7 Efficacy-Labeling Change With Clinical Data Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S007_Epivir.pdf
12/15/1997 SUPPL-6 Labeling

Label is not available on this site.

02/03/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/15/1997 SUPPL-4 Labeling

Label is not available on this site.

11/13/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/11/1997 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

07/31/1996 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
05/10/2019 SUPPL-38 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf
05/10/2019 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf
04/27/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf
09/25/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf
09/25/2017 SUPPL-36 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf
07/20/2016 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf
09/30/2015 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf
09/30/2015 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf
03/23/2015 SUPPL-32 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf
02/19/2015 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf
11/18/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf
10/25/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s027.pdf
06/13/2006 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf
11/22/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf
09/29/2004 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf
11/13/2003 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf
10/08/2002 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf
06/24/2002 SUPPL-16 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf

EPIVIR

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPIVIR LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription Yes AA 020596 VIIV HLTHCARE
LAMIVUDINE LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription No AA 077695 AUROBINDO PHARMA LTD
LAMIVUDINE LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription No AA 203564 LANNETT CO INC

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