Application 006383
- Type
- NDA
- Sponsor
- MALLINCKRODT INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | POWDER;FOR RX COMPOUNDING | 50GM/BOT | No | No |
| 003 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | POWDER;FOR RX COMPOUNDING | 100GM/BOT | No | No |
| 004 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | POWDER;FOR RX COMPOUNDING | 500GM/BOT | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-1510 | Methadone Hydrochloride | Methadone Hydrochloride | Mallinckrodt, Inc. | NDA | Current |