Application 200603
- Type
- NDA
- Sponsor
- SUNOVION PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LATUDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | Yes | Yes |
| 002 | LATUDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | Yes | No |
| 003 | LATUDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | Yes | No |
| 004 | LATUDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | Yes | No |
| 005 | LATUDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63402-302 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-302 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-302 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-302 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-304 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-304 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-304 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-304 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-306 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-306 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-306 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-306 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-308 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-308 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-308 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-308 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-312 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-312 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-312 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-312 | Latuda | lurasidone hydrochloride | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 70518-1812 | Latuda | lurasidone hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-1812 | Latuda | lurasidone hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-1824 | Latuda | lurasidone hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-1936 | Latuda | lurasidone hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-1936 | Latuda | lurasidone hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-3010 | Latuda | lurasidone hydrochloride | REMEDYREPACK INC. | NDA | Current |