Application 022202
- Type
- NDA
- Sponsor
- ASSERTIO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZIPSOR | DICLOFENAC POTASSIUM | CAPSULE;ORAL | 25MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13913-008 | ZIPSOR | diclofenac potassium | Depomed, Inc. | NDA | Current |
| 13913-008 | ZIPSOR | diclofenac potassium | Assertio Therapeutics, Inc. | NDA | Current |
| 13913-008 | ZIPSOR | diclofenac potassium | Depomed, Inc. | NDA | Current |
| 13913-008 | ZIPSOR | diclofenac potassium | Assertio Therapeutics, Inc. | NDA | Current |
| 69315-275 | Diclofenac Potassium | Diclofenac Potassium | Leading Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80389 | SUPPL | 2024-11-25 |
| 80388 | SUPPL | 2024-11-25 |
| 80307 | SUPPL | 2024-11-22 |
| 67607 | SUPPL | 2021-05-27 |
| 67606 | SUPPL | 2021-05-27 |
| 67595 | SUPPL | 2021-05-26 |
| 67594 | SUPPL | 2021-05-26 |
| 38377 | SUPPL | 2016-05-11 |
| 7042 | SUPPL | 2016-05-11 |
| 29399 | SUPPL | 2011-05-06 |
| 7041 | SUPPL | 2011-05-06 |
| 43836 | ORIG | 2011-02-15 |
| 44699 | ORIG | 2010-04-21 |
| 42448 | ORIG | 2010-04-21 |
| 29398 | ORIG | 2009-06-23 |
| 17079 | ORIG | 2009-06-22 |