Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022117

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SAPHRIS (ASENAPINE MALEATE)
EQ 2.5 BASE Marketing Status: Prescription

Active Ingredient: ASENAPINE MALEATE
Proprietary Name: SAPHRIS
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2.5 BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022117
Product Number: 003
Approval Date: Mar 12, 2015
Applicant Holder Full Name: FOREST LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SAPHRIS (ASENAPINE MALEATE)
EQ 5MG BASE Marketing Status: Prescription

Active Ingredient: ASENAPINE MALEATE
Proprietary Name: SAPHRIS
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022117
Product Number: 001
Approval Date: Aug 13, 2009
Applicant Holder Full Name: FOREST LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SAPHRIS (ASENAPINE MALEATE)
EQ 10MG BASE Marketing Status: Prescription

Active Ingredient: ASENAPINE MALEATE
Proprietary Name: SAPHRIS
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022117
Product Number: 002
Approval Date: Aug 13, 2009
Applicant Holder Full Name: FOREST LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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