Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206098

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ASENAPINE MALEATE (ASENAPINE MALEATE)
EQ 2.5MG BASE
Marketing Status: Prescription
Active Ingredient: ASENAPINE MALEATE
Proprietary Name: ASENAPINE MALEATE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206098
Product Number: 003
Approval Date: Jul 19, 2021
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ASENAPINE MALEATE (ASENAPINE MALEATE)
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: ASENAPINE MALEATE
Proprietary Name: ASENAPINE MALEATE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206098
Product Number: 001
Approval Date: Dec 10, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ASENAPINE MALEATE (ASENAPINE MALEATE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: ASENAPINE MALEATE
Proprietary Name: ASENAPINE MALEATE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206098
Product Number: 002
Approval Date: Dec 10, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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