Application 207537
- Type
- ANDA
- Sponsor
- PHARM ASSOC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | No | No |
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SOLUTION;ORAL | 10MG/5ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0406-6221 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-6225 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 76449 | ORIG | 2023-11-07 |