NDA 21003, held by Glaxosmithkline. Lamivudine.
As of Nov 14, 2026, NDA 21003 (Epivir-Hbv), held by Glaxosmithkline, was first approved by FDA on Dec 8, 1998, with 13 approved supplements and 0 published complete response letters.
| Nov 15, 2018 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Aug 16, 2001 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 8, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epivir-Hbv100MG · tablet;oral | Lamivudine | DiscontinuedReference drug |
| Dec 22, 2021 | Supplement 23Labeling · Standard review | Approved | |
| Nov 15, 2018 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Sep 27, 2017 | Supplement 17Labeling · Standard review | Approved | |
| May 8, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Dec 20, 2013 | Supplement 15Labeling · Standard review | Approved | |
| Jan 21, 2011 | Supplement 13Labeling | Approved | |
| Sep 26, 2007 | Supplement 10Labeling · Standard review | Approved | |
| Nov 22, 2004 | Supplement 5Labeling · Standard review | Approved | |
| Sep 27, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Nov 13, 2003 | Supplement 4Labeling · Standard review | Approved | |
| Sep 13, 2002 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 16, 2001 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 31, 2000 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 8, 1998 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
