Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204003

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DESVENLAFAXINE SUCCINATE (DESVENLAFAXINE SUCCINATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: DESVENLAFAXINE SUCCINATE
Proprietary Name: DESVENLAFAXINE SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204003
Product Number: 003
Approval Date: Sep 14, 2018
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DESVENLAFAXINE SUCCINATE (DESVENLAFAXINE SUCCINATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: DESVENLAFAXINE SUCCINATE
Proprietary Name: DESVENLAFAXINE SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204003
Product Number: 001
Approval Date: Jun 29, 2015
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DESVENLAFAXINE SUCCINATE (DESVENLAFAXINE SUCCINATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: DESVENLAFAXINE SUCCINATE
Proprietary Name: DESVENLAFAXINE SUCCINATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204003
Product Number: 002
Approval Date: Jun 29, 2015
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information