Application 021005
- Type
- NDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOLARAZE | DICLOFENAC SODIUM | GEL;TOPICAL | 3% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0803 | DICLOFENAC SODIUM | diclofenac sodium | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0168-0844 | DICLOFENAC SODIUM | diclofenac sodium | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 10337-803 | Solaraze | diclofenac sodium | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-844 | Solaraze | diclofenac sodium | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-844 | Solaraze | diclofenac sodium | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80373 | SUPPL | 2024-11-25 |
| 80302 | SUPPL | 2024-11-22 |
| 72637 | SUPPL | 2022-11-17 |
| 72636 | SUPPL | 2022-11-17 |
| 72618 | SUPPL | 2022-11-15 |
| 70713 | SUPPL | 2022-04-06 |
| 70712 | SUPPL | 2022-04-06 |
| 70706 | SUPPL | 2022-04-06 |
| 67381 | SUPPL | 2021-05-03 |
| 67266 | SUPPL | 2021-04-30 |
| 23215 | SUPPL | 2016-05-18 |
| 14147 | SUPPL | 2016-05-11 |
| 4018 | SUPPL | 2016-05-11 |
| 26461 | SUPPL | 2011-12-14 |
| 14146 | SUPPL | 2011-12-14 |
| 26460 | SUPPL | 2007-06-07 |
| 4017 | SUPPL | 2004-07-28 |
| 26459 | SUPPL | 2004-03-24 |
| 21349 | ORIG | 2003-07-08 |
| 35862 | SUPPL | 2003-05-29 |
| 26458 | SUPPL | 2003-05-29 |
| 14145 | ORIG | 2000-10-16 |
| 4016 | ORIG | 2000-10-16 |