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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204065

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NDA 204065 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 six 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. Twelve suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

Summary for 204065

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 204065

Suppliers and Packaging for NDA: 204065

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204065 ANDA Actavis Pharma, Inc. 0591-3659 0591-3659-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-3659-30)
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204065 ANDA Actavis Pharma, Inc. 0591-3659 0591-3659-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-3659-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Jul 29, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Jan 25, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Jul 29, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Jul 29, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Aug 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE


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Serving leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
Medtronic
Queensland Health
Julphar
Cantor Fitzgerald
US Army
Cerilliant
Farmers Insurance
McKesson

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