Details for New Drug Application (NDA): 213248
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NDA 213248 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys, Heritage Pharma Avet, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in eighteen NDAs. It is available from twenty-eight 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. Twenty-nine 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 213248
| Tradename: | LURASIDONE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | lurasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213248
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 213248 | ANDA | Alembic Pharmaceuticals Limited | 46708-494 | 46708-494-10 | 100 BLISTER PACK in 1 CARTON (46708-494-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 213248 | ANDA | Alembic Pharmaceuticals Limited | 46708-494 | 46708-494-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-494-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 13, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | May 13, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | May 13, 2021 | TE: | AB | RLD: | No | ||||
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