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Serving leading biopharmaceutical companies globally:

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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204095

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NDA 204095 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Sandoz Inc, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DESVENLAFAXINE SUCCINATE profile page.

The generic ingredient in DESVENLAFAXINE SUCCINATE is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 204095
Tradename:DESVENLAFAXINE SUCCINATE
Applicant:Mylan Pharms Inc
Ingredient:desvenlafaxine succinate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204095 ANDA Mylan Pharmaceuticals Inc. 0378-4230 0378-4230-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4230-77)
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204095 ANDA Mylan Pharmaceuticals Inc. 0378-4230 0378-4230-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4230-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Jun 29, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Jun 29, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

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