Application 208002
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 002 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
| 003 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 004 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No |
| 005 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-082 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-879 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-880 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-881 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-882 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57732 | ORIG | 2019-02-21 |