Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200603

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LATUDA (LURASIDONE HYDROCHLORIDE)
20MG Marketing Status: Prescription

Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LATUDA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200603
Product Number: 003
Approval Date: Dec 7, 2011
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LATUDA (LURASIDONE HYDROCHLORIDE)
40MG Marketing Status: Prescription

Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LATUDA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N200603
Product Number: 001
Approval Date: Oct 28, 2010
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LATUDA (LURASIDONE HYDROCHLORIDE)
60MG Marketing Status: Prescription

Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LATUDA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200603
Product Number: 005
Approval Date: Jul 12, 2013
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LATUDA (LURASIDONE HYDROCHLORIDE)
80MG Marketing Status: Prescription

Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LATUDA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200603
Product Number: 002
Approval Date: Oct 28, 2010
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LATUDA (LURASIDONE HYDROCHLORIDE)
120MG Marketing Status: Prescription

Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LATUDA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200603
Product Number: 004
Approval Date: Apr 26, 2012
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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