Application 020518
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RETROVIR | ZIDOVUDINE | TABLET;ORAL | 200MG | No | No |
| 002 | RETROVIR | ZIDOVUDINE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 34756 | SUPPL | 2015-01-08 |
| 25098 | SUPPL | 2014-12-31 |
| 34755 | SUPPL | 2012-06-06 |
| 25097 | SUPPL | 2012-06-04 |
| 25096 | SUPPL | 2011-12-01 |
| 34754 | SUPPL | 2011-11-25 |
| 25095 | SUPPL | 2010-05-21 |
| 34753 | SUPPL | 2010-05-18 |
| 25094 | SUPPL | 2010-01-06 |
| 12674 | SUPPL | 2009-11-23 |
| 12673 | SUPPL | 2008-09-25 |
| 2654 | SUPPL | 2008-09-23 |
| 2653 | SUPPL | 2006-12-04 |
| 34752 | SUPPL | 2006-11-22 |
| 2652 | SUPPL | 2006-05-18 |
| 12672 | SUPPL | 2006-05-16 |
| 20696 | SUPPL | 2005-04-19 |
| 34751 | SUPPL | 2004-03-11 |
| 25093 | SUPPL | 2004-03-11 |
| 34749 | SUPPL | 2003-04-25 |
| 34750 | SUPPL | 2003-04-04 |
| 2651 | SUPPL | 2002-12-18 |
| 2650 | SUPPL | 2002-02-21 |
| 34748 | SUPPL | 2001-03-30 |
| 25092 | SUPPL | 2001-03-30 |