Details for New Drug Application (NDA): 212244
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NDA 212244 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, 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-seven 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 212244
| Tradename: | LURASIDONE HYDROCHLORIDE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | lurasidone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212244
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 212244 | ANDA | Major Pharmaceuticals | 0904-7355 | 0904-7355-04 | 30 BLISTER PACK in 1 CARTON (0904-7355-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 212244 | ANDA | Major Pharmaceuticals | 0904-7356 | 0904-7356-61 | 100 BLISTER PACK in 1 CARTON (0904-7356-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 13, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Dec 13, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Dec 13, 2022 | TE: | AB | RLD: | No | ||||
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