Details for New Drug Application (NDA): 212091
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The generic ingredient in LURASIDONE HYDROCHLORIDE is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 212091
Tradename: | LURASIDONE HYDROCHLORIDE |
Applicant: | Slate Run Pharma |
Ingredient: | lurasidone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 212091
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 212091 | ANDA | A-S Medication Solutions | 50090-7078 | 50090-7078-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7078-0) |
LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 212091 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-093 | 70436-093-01 | 100 TABLET, FILM COATED in 1 BOTTLE (70436-093-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 28, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Dec 28, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Dec 28, 2020 | TE: | AB | RLD: | No |
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