Application 088109
- Type
- ANDA
- Sponsor
- ROXANE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0710 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76460 | ORIG | 2023-11-07 |