Application 212091
- Type
- ANDA
- Sponsor
- PIRAMAL HLTHCARE UK
Application Products#
Product, Drug, Ingredient table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 63102 | ORIG | 2020-05-19 |