Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 212268

Expand all

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: No
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: Yes
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English