Application 021123
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ULTRACET | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 325MG;37.5MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-143 | ULTRACET | tramadol hydrochloride and acetaminophen | Rebel Distributors Corp | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-650 | ULTRACET | tramadol hydrochloride and acetaminophen | Janssen Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76233 | ORIG | 2023-11-03 |
| 76232 | ORIG | 2023-11-03 |
| 73503 | SUPPL | 2023-02-14 |
| 73502 | SUPPL | 2023-02-14 |
| 73490 | SUPPL | 2023-02-14 |
| 68612 | SUPPL | 2021-09-14 |
| 68606 | SUPPL | 2021-09-13 |
| 68605 | SUPPL | 2021-09-13 |
| 66593 | SUPPL | 2021-03-08 |
| 66592 | SUPPL | 2021-03-08 |
| 66548 | SUPPL | 2021-03-05 |
| 60345 | SUPPL | 2019-10-08 |
| 60333 | SUPPL | 2019-10-08 |
| 60332 | SUPPL | 2019-10-08 |
| 55975 | SUPPL | 2018-10-17 |
| 55974 | SUPPL | 2018-10-17 |
| 55669 | SUPPL | 2018-09-28 |
| 55668 | SUPPL | 2018-09-28 |
| 49626 | SUPPL | 2017-08-30 |
| 49597 | SUPPL | 2017-08-30 |
| 46362 | SUPPL | 2016-12-21 |
| 46361 | SUPPL | 2016-12-21 |
| 46360 | SUPPL | 2016-12-21 |
| 46273 | SUPPL | 2016-12-20 |
| 46272 | SUPPL | 2016-12-20 |
| 46271 | SUPPL | 2016-12-20 |
| 14441 | SUPPL | 2013-10-22 |
| 26832 | SUPPL | 2013-10-21 |
| 14440 | SUPPL | 2011-06-29 |
| 4384 | SUPPL | 2011-06-28 |
| 26831 | SUPPL | 2009-11-10 |
| 36162 | SUPPL | 2009-09-17 |
| 14439 | SUPPL | 2004-05-03 |
| 26830 | SUPPL | 2004-04-20 |
| 41964 | ORIG | 2001-08-15 |
| 36161 | ORIG | 2001-08-15 |
| 26829 | ORIG | 2001-08-15 |