Application 210484
- Type
- ANDA
- Sponsor
- NOSTRUM LABS INC
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 |
|---|---|---|---|---|---|
| 68462-800 | Methadone Hydrochloride | Methadone Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-800 | Methadone Hydrochloride | Methadone Hydrochloride | Glenmark Pharmaceuticals, Inc., USA | ANDA | Current |
| 68462-801 | Methadone Hydrochloride | Methadone Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-801 | Methadone Hydrochloride | Methadone Hydrochloride | Glenmark Pharmaceuticals, Inc., USA | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76428 | ORIG | 2023-11-07 |