Application 022165
- Type
- NDA
- Sponsor
- ASSERTIO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAMBIA | DICLOFENAC POTASSIUM | FOR SOLUTION;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13913-011 | Cambia | diclofenac potassium | Depomed, Inc. | NDA | Current |
| 13913-011 | Cambia | diclofenac potassium | Assertio Therapeutics, Inc. | NDA | Current |
| 13913-012 | Cambia | diclofenac potassium | Depomed, Inc. | NDA | Current |
| 13913-012 | Cambia | diclofenac potassium | Assertio Therapeutics, Inc. | NDA | Current |
| 13913-012 | Cambia | diclofenac potassium | Assertio Therapeutics, Inc. | NDA | Current |
| 50192-113 | CAMBIA | Diclofenac Potassium | Nautilus Neurosciences, Inc. | NDA | Current |
| 69315-506 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | Leading Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80403 | SUPPL | 2024-11-25 |
| 80402 | SUPPL | 2024-11-25 |
| 80306 | SUPPL | 2024-11-22 |
| 78236 | SUPPL | 2024-04-24 |
| 78235 | SUPPL | 2024-04-24 |
| 67346 | SUPPL | 2021-05-03 |
| 67345 | SUPPL | 2021-05-03 |
| 67344 | SUPPL | 2021-05-03 |
| 67272 | SUPPL | 2021-04-30 |
| 67271 | SUPPL | 2021-04-30 |
| 47693 | SUPPL | 2017-03-24 |
| 47631 | SUPPL | 2017-03-22 |
| 47629 | SUPPL | 2017-03-21 |
| 38329 | SUPPL | 2016-05-11 |
| 6995 | SUPPL | 2016-05-11 |
| 29347 | SUPPL | 2011-07-25 |
| 44689 | ORIG | 2010-05-27 |
| 42435 | SUPPL | 2010-05-27 |
| 24252 | SUPPL | 2010-05-27 |
| 21951 | ORIG | 2010-05-27 |
| 43829 | SUPPL | 2009-11-16 |
| 29346 | ORIG | 2009-07-23 |
| 6994 | SUPPL | 2009-07-23 |
| 38328 | SUPPL | 2009-06-22 |
| 38327 | ORIG | 2009-06-22 |