Application 017058
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET, FOR SUSPENSION;ORAL | 40MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-4538 | DISKETS | Methadone Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-4538 | DISKETS | Methadone Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-4538 | DISKETS | Methadone Hydrochloride | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4538 | DISKETS | Methadone Hydrochloride | West-Ward Pharmaceuticals Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84704 | SUPPL | 2026-01-07 |
| 84553 | SUPPL | 2025-12-29 |
| 77025 | SUPPL | 2023-12-19 |
| 76947 | SUPPL | 2023-12-18 |
| 67682 | SUPPL | 2021-06-03 |
| 67680 | SUPPL | 2021-06-03 |
| 60297 | SUPPL | 2019-10-08 |
| 60291 | SUPPL | 2019-10-08 |
| 52285 | SUPPL | 2018-02-02 |
| 52236 | SUPPL | 2018-02-01 |
| 46407 | SUPPL | 2016-12-21 |
| 46406 | SUPPL | 2016-12-21 |
| 46208 | SUPPL | 2016-12-19 |
| 46207 | SUPPL | 2016-12-19 |
| 10956 | SUPPL | 2013-09-24 |
| 537 | SUPPL | 2013-09-20 |
| 33221 | SUPPL | 2008-02-14 |
| 536 | SUPPL | 2008-02-07 |
| 13078 | SUPPL | 2006-12-28 |
| 10955 | SUPPL | 2006-12-14 |