Application 020978
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZIAGEN | ABACAVIR SULFATE | SOLUTION;ORAL | EQ 20MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49702-222 | ZIAGEN | abacavir sulfate | ViiV Healthcare Company | NDA | Current |
| 49702-222 | ZIAGEN | abacavir sulfate | ViiV Healthcare Company | NDA | Current |
| 49702-222 | ZIAGEN | abacavir sulfate | ViiV Healthcare Company | NDA | Current |
| 49702-222 | ZIAGEN | abacavir sulfate | ViiV Healthcare Company | NDA | Current |
| 49702-222 | ZIAGEN | abacavir sulfate | ViiV Healthcare Company | NDA | Current |
| 49702-222 | ZIAGEN | abacavir sulfate | ViiV Healthcare Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65352 | SUPPL | 2020-11-27 |
| 65339 | SUPPL | 2020-11-25 |
| 65338 | SUPPL | 2020-11-25 |
| 54256 | SUPPL | 2018-05-18 |
| 54255 | SUPPL | 2018-05-18 |
| 54253 | SUPPL | 2018-05-18 |
| 54076 | SUPPL | 2018-05-10 |
| 54075 | SUPPL | 2018-05-10 |
| 47687 | SUPPL | 2017-03-24 |
| 47621 | SUPPL | 2017-03-21 |
| 35782 | SUPPL | 2015-10-07 |
| 3927 | SUPPL | 2015-10-02 |
| 35780 | SUPPL | 2015-04-01 |
| 3925 | SUPPL | 2015-03-25 |
| 3926 | SUPPL | 2015-02-24 |
| 35781 | SUPPL | 2015-02-20 |
| 35779 | SUPPL | 2013-09-17 |
| 26368 | SUPPL | 2013-09-13 |
| 35778 | SUPPL | 2012-05-22 |
| 3924 | SUPPL | 2012-05-22 |
| 3923 | SUPPL | 2012-03-19 |
| 14077 | SUPPL | 2012-03-16 |
| 35777 | SUPPL | 2011-11-22 |
| 26367 | SUPPL | 2011-11-22 |
| 3922 | SUPPL | 2011-05-17 |
| 3921 | SUPPL | 2010-08-10 |
| 26365 | SUPPL | 2009-08-25 |
| 3915 | SUPPL | 2009-08-25 |
| 35776 | SUPPL | 2009-01-02 |
| 3920 | SUPPL | 2008-12-29 |
| 3919 | SUPPL | 2008-07-23 |
| 35775 | SUPPL | 2008-07-22 |
| 41858 | SUPPL | 2007-09-26 |
| 21324 | SUPPL | 2007-09-26 |
| 21323 | SUPPL | 2007-09-26 |
| 14076 | SUPPL | 2007-05-09 |
| 3918 | SUPPL | 2007-05-09 |
| 3917 | SUPPL | 2006-08-21 |
| 35774 | SUPPL | 2006-08-14 |
| 14074 | SUPPL | 2004-08-05 |
| 3916 | SUPPL | 2004-08-05 |
| 26366 | SUPPL | 2004-07-28 |
| 14075 | SUPPL | 2004-07-28 |
| 35773 | SUPPL | 2004-05-03 |
| 3914 | SUPPL | 2004-04-20 |
| 41857 | SUPPL | 2004-04-14 |
| 23613 | ORIG | 2003-12-12 |
| 14073 | SUPPL | 2003-09-25 |
| 26364 | SUPPL | 2003-07-28 |
| 26363 | SUPPL | 2002-10-02 |
| 14071 | SUPPL | 2002-10-02 |
| 14072 | SUPPL | 2002-08-14 |
| 3913 | SUPPL | 2002-08-14 |
| 26362 | SUPPL | 2002-01-28 |
| 35772 | ORIG | 1998-12-17 |
| 26361 | ORIG | 1998-12-17 |
| 21322 | ORIG | 1998-12-17 |
| 51225 | SUPPL | 1900-01-01 |
| 51224 | SUPPL | 1900-01-01 |
| 51223 | SUPPL | 1900-01-01 |