Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212268

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SECUADO (ASENAPINE)
3.8MG/24HR
Marketing Status: Prescription

Active Ingredient: ASENAPINE
Proprietary Name: SECUADO
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 3.8MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212268
Product Number: 001
Approval Date: Oct 11, 2019
Applicant Holder Full Name: HISAMITSU PHARMACEUTICAL CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SECUADO (ASENAPINE)
5.7MG/24HR
Marketing Status: Prescription

Active Ingredient: ASENAPINE
Proprietary Name: SECUADO
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 5.7MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212268
Product Number: 002
Approval Date: Oct 11, 2019
Applicant Holder Full Name: HISAMITSU PHARMACEUTICAL CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SECUADO (ASENAPINE)
7.6MG/24HR
Marketing Status: Prescription

Active Ingredient: ASENAPINE
Proprietary Name: SECUADO
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 7.6MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212268
Product Number: 003
Approval Date: Oct 11, 2019
Applicant Holder Full Name: HISAMITSU PHARMACEUTICAL CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information