Application 021624
- Type
- NDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-217 | Methadone Hydrochloride | Methadone Hydrochloride | Mylan Institutional LLC | NDA | Current |
| 67457-217 | Methadone Hydrochloride | Methadone Hydrochloride | Mylan Institutional LLC | NDA | Current |
| 67457-217 | Methadone Hydrochloride | Methadone Hydrochloride | Mylan Institutional LLC | NDA | Current |
| 67457-217 | Methadone Hydrochloride | Methadone Hydrochloride | Mylan Institutional LLC | NDA | Current |
| 67457-217 | Methadone Hydrochloride | Methadone Hydrochloride | Mylan Institutional LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84685 | SUPPL | 2026-01-06 |
| 84602 | SUPPL | 2025-12-31 |
| 77004 | SUPPL | 2023-12-19 |
| 76916 | SUPPL | 2023-12-18 |
| 71188 | SUPPL | 2022-06-01 |
| 71145 | SUPPL | 2022-05-25 |
| 67697 | SUPPL | 2021-06-07 |
| 67684 | SUPPL | 2021-06-03 |
| 60287 | SUPPL | 2019-10-08 |
| 46352 | SUPPL | 2016-12-21 |
| 46289 | SUPPL | 2016-12-20 |
| 21760 | SUPPL | 2013-06-03 |
| 37346 | SUPPL | 2004-03-03 |
| 5871 | SUPPL | 2004-02-27 |