Application 050739
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMNICEF | CEFDINIR | CAPSULE;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30415 | SUPPL | 2015-11-20 |
| 18147 | SUPPL | 2015-11-19 |
| 39220 | SUPPL | 2009-01-02 |
| 8149 | SUPPL | 2008-12-19 |
| 8148 | SUPPL | 2007-09-25 |
| 39219 | SUPPL | 2007-09-19 |
| 30414 | SUPPL | 2007-07-05 |
| 18146 | SUPPL | 2007-06-27 |
| 42709 | ORIG | 2006-01-03 |
| 30413 | SUPPL | 2005-07-21 |
| 18145 | SUPPL | 2005-07-21 |
| 30412 | SUPPL | 2004-09-03 |
| 8147 | SUPPL | 2002-07-24 |
| 39218 | SUPPL | 1999-11-24 |
| 30411 | SUPPL | 1999-11-24 |