Details for New Drug Application (NDA): 212124
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NDA 212124 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Heritage Pharma Avet, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the LURASIDONE HYDROCHLORIDE profile page.
The generic ingredient in LURASIDONE HYDROCHLORIDE is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
The generic ingredient in LURASIDONE HYDROCHLORIDE is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 212124
| Tradename: | LURASIDONE HYDROCHLORIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | lurasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212124
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 212124 | ANDA | Macleods Pharmaceuticals Limited | 33342-419 | 33342-419-07 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-419-07) |
| LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 212124 | ANDA | Macleods Pharmaceuticals Limited | 33342-419 | 33342-419-10 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-419-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 9, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jun 9, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jun 9, 2023 | TE: | AB | RLD: | No | ||||
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