Application 020947
- Type
- NDA
- Sponsor
- NUVO PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENNSAID | DICLOFENAC SODIUM | SOLUTION;TOPICAL | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 26282 | SUPPL | 2016-05-11 |
| 13807 | SUPPL | 2016-05-11 |
| 13806 | SUPPL | 2016-05-11 |
| 3835 | SUPPL | 2016-05-11 |
| 26281 | SUPPL | 2013-10-24 |
| 35704 | SUPPL | 2013-10-21 |
| 26280 | SUPPL | 2011-07-18 |
| 24184 | ORIG | 2010-05-06 |
| 21297 | ORIG | 2010-05-06 |
| 35703 | SUPPL | 2010-04-04 |
| 13805 | SUPPL | 2010-04-04 |
| 26279 | SUPPL | 2010-03-31 |
| 3834 | SUPPL | 2010-03-31 |
| 43687 | ORIG | 2009-11-18 |
| 26278 | ORIG | 2009-11-13 |
| 13804 | ORIG | 2009-11-12 |