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Details for New Drug Application (NDA): 200603

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NDA 200603 describes LATUDA, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LATUDA profile page.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. There are twenty-nine tentative approvals for this compound. Additional details are available on the lurasidone hydrochloride profile page.

Summary for NDA: 200603

Tradename:
LATUDA
Applicant:
Sunovion Pharms Inc
Ingredient:
lurasidone hydrochloride
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 200603

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 Sunovion Pharmaceuticals 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 Sunovion Pharmaceuticals 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 28, 2010TE:RLD:Yes
Patent:5,532,372Patent Expiration:Jul 2, 2018Product Flag?Substance Flag?YDelist Request?
Patent:8,729,085Patent Expiration:May 26, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,883,794Patent Expiration:May 26, 2026Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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