Application 020564
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPIVIR | LAMIVUDINE | TABLET;ORAL | 150MG | Yes | No |
| 003 | EPIVIR | LAMIVUDINE | TABLET;ORAL | 300MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-367 | EPIVIR | lamivudine | Rebel Distributors Corp | NDA | Current |
| 49702-203 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-203 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-203 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-203 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-204 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-204 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-204 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 49702-204 | EPIVIR | lamivudine | ViiV Healthcare Company | NDA | Current |
| 50090-0550 | EPIVIR | lamivudine | A-S Medication Solutions | NDA | Current |
| 53808-0245 | EPIVIR | lamivudine | State of Florida DOH Central Pharmacy | NDA | Current |
| 53808-0246 | EPIVIR | lamivudine | State of Florida DOH Central Pharmacy | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58707 | SUPPL | 2019-05-15 |
| 58682 | SUPPL | 2019-05-14 |
| 57663 | ORIG | 2019-02-15 |
| 54028 | SUPPL | 2018-05-07 |
| 53921 | SUPPL | 2018-05-01 |
| 50015 | SUPPL | 2017-10-12 |
| 2754 | SUPPL | 2016-07-22 |
| 34861 | SUPPL | 2016-07-21 |
| 34860 | SUPPL | 2015-10-07 |
| 25203 | SUPPL | 2015-10-02 |
| 34858 | SUPPL | 2015-04-14 |
| 2752 | SUPPL | 2015-03-26 |
| 2753 | SUPPL | 2015-02-24 |
| 34859 | SUPPL | 2015-02-20 |
| 34857 | SUPPL | 2011-12-02 |
| 25202 | SUPPL | 2011-11-22 |
| 34856 | SUPPL | 2008-02-14 |
| 2751 | SUPPL | 2008-02-07 |
| 41438 | SUPPL | 2007-09-26 |
| 41437 | SUPPL | 2007-09-26 |
| 41435 | SUPPL | 2007-09-26 |
| 20730 | SUPPL | 2007-09-26 |
| 2750 | SUPPL | 2006-10-31 |
| 34855 | SUPPL | 2006-10-26 |
| 25201 | SUPPL | 2006-06-20 |
| 34854 | SUPPL | 2006-06-14 |
| 41436 | SUPPL | 2005-01-06 |
| 12748 | SUPPL | 2004-12-03 |
| 2749 | SUPPL | 2004-12-02 |
| 34853 | SUPPL | 2004-10-04 |
| 25200 | SUPPL | 2004-10-04 |
| 12747 | SUPPL | 2003-12-02 |
| 25199 | SUPPL | 2003-11-25 |
| 25197 | SUPPL | 2002-10-08 |
| 12745 | SUPPL | 2002-10-08 |
| 25198 | SUPPL | 2002-06-24 |
| 12746 | SUPPL | 2002-06-24 |
| 2748 | SUPPL | 2002-03-01 |
| 25196 | SUPPL | 2001-03-06 |
| 51228 | SUPPL | 1900-01-01 |
| 51227 | SUPPL | 1900-01-01 |
| 51226 | SUPPL | 1900-01-01 |