Application 020413
- Type
- NDA
- Sponsor
- BRISTOL-MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZERIT | STAVUDINE | FOR SOLUTION;ORAL | 1MG/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0003-1968 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56918 | SUPPL | 2018-12-21 |
| 56779 | SUPPL | 2018-12-18 |
| 56778 | SUPPL | 2018-12-18 |
| 50868 | SUPPL | 2017-12-27 |
| 50821 | SUPPL | 2017-12-21 |
| 12565 | SUPPL | 2011-11-22 |
| 2522 | SUPPL | 2011-11-22 |
| 24947 | SUPPL | 2011-05-16 |
| 24946 | SUPPL | 2010-12-28 |
| 12564 | SUPPL | 2010-12-23 |
| 24945 | SUPPL | 2009-07-15 |
| 34637 | SUPPL | 2009-07-09 |
| 12563 | SUPPL | 2009-02-20 |
| 2521 | SUPPL | 2009-02-18 |
| 12562 | SUPPL | 2009-01-02 |
| 2520 | SUPPL | 2008-12-18 |
| 12561 | SUPPL | 2008-04-23 |
| 12560 | SUPPL | 2008-04-23 |
| 2519 | SUPPL | 2008-04-16 |
| 2518 | SUPPL | 2008-04-16 |
| 2517 | SUPPL | 2007-06-14 |
| 2516 | SUPPL | 2007-04-25 |
| 34636 | SUPPL | 2007-02-05 |
| 34635 | SUPPL | 2004-06-07 |
| 2515 | SUPPL | 2004-06-07 |
| 34634 | SUPPL | 2003-04-25 |
| 12559 | SUPPL | 2002-03-29 |
| 2514 | SUPPL | 2002-03-29 |
| 24944 | SUPPL | 2002-02-20 |
| 24943 | SUPPL | 2002-02-20 |