Application 074184
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHADOSE | METHADONE HYDROCHLORIDE | TABLET, FOR SUSPENSION;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-0540 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0540 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0540 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0540 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0540 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-0540 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | SpecGx LLC | ANDA | Current |
| 60687-209 | METHADOSE DISPERSIBLE | Methadone Hydrochloride | American Health Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44247 | ORIG | 2006-11-27 |