Details for New Drug Application (NDA): 208058
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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 208058
Tradename: | LURASIDONE HYDROCHLORIDE |
Applicant: | Avet Lifesciences |
Ingredient: | lurasidone hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 208058
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208058 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-887 | 23155-887-18 | 121000 TABLET, FILM COATED in 1 CONTAINER (23155-887-18) |
LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208058 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-888 | 23155-888-18 | 60500 TABLET, FILM COATED in 1 CONTAINER (23155-888-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Sep 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Sep 4, 2019 | TE: | AB | RLD: | No |
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