Application 020596
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPIVIR | LAMIVUDINE | SOLUTION;ORAL | 10MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49702-205 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-205 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-205 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-205 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58708 | SUPPL | 2019-05-15 |
| 58684 | SUPPL | 2019-05-14 |
| 54029 | SUPPL | 2018-05-07 |
| 53929 | SUPPL | 2018-05-01 |
| 50016 | SUPPL | 2017-10-12 |
| 25285 | SUPPL | 2016-07-22 |
| 34932 | SUPPL | 2016-07-21 |
| 34931 | SUPPL | 2015-10-07 |
| 25284 | SUPPL | 2015-10-02 |
| 34930 | SUPPL | 2015-04-14 |
| 25282 | SUPPL | 2015-03-26 |
| 25283 | SUPPL | 2015-02-24 |
| 12811 | SUPPL | 2015-02-20 |
| 12810 | SUPPL | 2011-12-02 |
| 2831 | SUPPL | 2011-11-22 |
| 41462 | SUPPL | 2007-09-26 |
| 41461 | SUPPL | 2007-09-26 |
| 41460 | SUPPL | 2007-09-26 |
| 20752 | SUPPL | 2007-09-26 |
| 20750 | SUPPL | 2007-09-26 |
| 2830 | SUPPL | 2006-11-06 |
| 34929 | SUPPL | 2006-10-26 |
| 25281 | SUPPL | 2006-06-20 |
| 34928 | SUPPL | 2006-06-14 |
| 20751 | SUPPL | 2005-01-06 |
| 12809 | SUPPL | 2004-12-03 |
| 25279 | SUPPL | 2004-12-02 |
| 34927 | SUPPL | 2004-10-04 |
| 25280 | SUPPL | 2004-10-04 |
| 34926 | SUPPL | 2003-12-02 |
| 2829 | SUPPL | 2003-11-25 |
| 34924 | SUPPL | 2002-10-08 |
| 25277 | SUPPL | 2002-10-08 |
| 34925 | SUPPL | 2002-06-24 |
| 2828 | SUPPL | 2002-06-24 |
| 25278 | SUPPL | 2002-03-01 |
| 25276 | SUPPL | 2001-03-06 |
| 53540 | ORIG | 1900-01-01 |
| 53539 | ORIG | 1900-01-01 |
| 53538 | ORIG | 1900-01-01 |