Details for New Drug Application (NDA): 208045
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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-five suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 208045
Tradename: | LURASIDONE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | lurasidone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208045
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208045 | ANDA | Aurobindo Pharma Limited | 65862-953 | 65862-953-05 | 500 TABLET in 1 BOTTLE (65862-953-05) |
LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208045 | ANDA | Aurobindo Pharma Limited | 65862-953 | 65862-953-30 | 30 TABLET in 1 BOTTLE (65862-953-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Mar 10, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Mar 10, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Mar 10, 2023 | TE: | AB | RLD: | No |
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