Details for New Drug Application (NDA): 200603
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The generic ingredient in LATUDA 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 200603
Tradename: | LATUDA |
Applicant: | Sunovion Pharms Inc |
Ingredient: | lurasidone hydrochloride |
Patents: | 9 |
Suppliers and Packaging for NDA: 200603
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603 | NDA | Sumitomo Pharma America, Inc. | 63402-302 | 63402-302-04 | 4 BLISTER PACK in 1 CARTON (63402-302-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-07) |
LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603 | NDA | Sumitomo Pharma America, Inc. | 63402-302 | 63402-302-10 | 10 BLISTER PACK in 1 CARTON (63402-302-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Oct 28, 2010 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 20, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 200603
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