Application 040517
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-5755 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5755 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5755 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5755 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5771 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5771 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5771 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 0406-5771 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | ANDA | Current |
| 52959-386 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | H.J. Harkins Company Inc. | ANDA | Current |
| 52959-435 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | H.J. Harkins Company Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44514 | ORIG | 2015-06-30 |