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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 204082


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NDA 204082 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Mylan, Rubicon, Yichang Humanwell, and Zydus Pharms, and is included in ten NDAs. It is available from twenty 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. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 204082
Tradename:DESVENLAFAXINE SUCCINATE
Applicant:Hikma
Ingredient:desvenlafaxine succinate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204082
Suppliers and Packaging for NDA: 204082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204082 ANDA Hikma Pharmaceuticals USA Inc. 0054-0400 0054-0400-13 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-13)
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204082 ANDA Hikma Pharmaceuticals USA Inc. 0054-0400 0054-0400-22 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Feb 16, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Aug 28, 2017TE:ABRLD:No

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