Application 021196
- Type
- NDA
- Sponsor
- JAZZ PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYREM | SODIUM OXYBATE | SOLUTION;ORAL | 500MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-9628 | N/A | sodium oxybate | Hikma Pharmaceuticals USA Inc. | NDA AUTHORIZED GENERIC | Current |
| 68727-100 | Xyrem | sodium oxybate | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-100 | Xyrem | sodium oxybate | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-100 | Xyrem | sodium oxybate | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-100 | Xyrem | sodium oxybate | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-100 | Xyrem | sodium oxybate | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 68727-100 | Xyrem | sodium oxybate | Jazz Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82975 | SUPPL | 2025-07-29 |
| 82299 | SUPPL | 2025-05-23 |
| 81435 | SUPPL | 2025-03-04 |
| 80244 | SUPPL | 2024-11-19 |
| 78548 | SUPPL | 2024-05-23 |
| 77234 | SUPPL | 2024-01-17 |
| 73969 | SUPPL | 2023-04-10 |
| 73968 | SUPPL | 2023-04-10 |
| 73950 | SUPPL | 2023-04-05 |
| 72312 | SUPPL | 2022-10-12 |
| 71890 | SUPPL | 2022-08-25 |
| 71889 | SUPPL | 2022-08-25 |
| 71857 | SUPPL | 2022-08-23 |
| 70138 | SUPPL | 2022-02-10 |
| 69543 | SUPPL | 2021-12-14 |
| 68369 | SUPPL | 2021-08-13 |
| 66236 | SUPPL | 2021-02-17 |
| 66227 | SUPPL | 2021-02-16 |
| 64755 | SUPPL | 2020-09-29 |
| 64754 | SUPPL | 2020-09-29 |
| 64722 | SUPPL | 2020-09-29 |
| 64001 | SUPPL | 2020-07-22 |
| 64000 | SUPPL | 2020-07-22 |
| 63999 | SUPPL | 2020-07-22 |
| 63998 | SUPPL | 2020-07-22 |
| 63997 | SUPPL | 2020-07-22 |
| 63996 | SUPPL | 2020-07-22 |
| 60056 | SUPPL | 2019-09-20 |
| 59980 | SUPPL | 2019-09-12 |
| 59971 | SUPPL | 2019-09-11 |
| 56139 | SUPPL | 2018-10-29 |
| 56118 | SUPPL | 2018-10-26 |
| 56117 | SUPPL | 2018-10-26 |
| 54059 | SUPPL | 2018-05-08 |
| 50450 | SUPPL | 2017-11-17 |
| 50436 | SUPPL | 2017-11-17 |
| 48960 | SUPPL | 2017-07-13 |
| 47012 | SUPPL | 2017-01-30 |
| 46991 | SUPPL | 2017-01-26 |
| 14621 | SUPPL | 2016-02-24 |
| 4611 | SUPPL | 2015-07-16 |
| 44473 | ORIG | 2015-07-07 |
| 4610 | SUPPL | 2015-03-02 |
| 36323 | SUPPL | 2014-04-14 |
| 27039 | SUPPL | 2014-04-14 |
| 27038 | SUPPL | 2012-12-20 |
| 44104 | ORIG | 2012-12-17 |
| 14620 | SUPPL | 2012-12-17 |
| 27037 | SUPPL | 2006-11-16 |
| 27036 | SUPPL | 2006-07-03 |
| 27034 | SUPPL | 2005-11-22 |
| 14619 | SUPPL | 2005-11-22 |
| 27035 | SUPPL | 2005-09-22 |
| 27033 | SUPPL | 2003-11-25 |
| 21503 | ORIG | 2002-07-17 |
| 14618 | ORIG | 2002-07-17 |
| 4609 | ORIG | 2002-07-17 |