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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204028


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NDA 204028 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, 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 204028
Tradename:DESVENLAFAXINE SUCCINATE
Applicant:Rubicon
Ingredient:desvenlafaxine succinate
Patents:0
Medical Subject Heading (MeSH) Categories for 204028
Suppliers and Packaging for NDA: 204028
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204028 ANDA A-S Medication Solutions 50090-7190 50090-7190-0 30 TABLET, EXTENDED RELEASE in 1 PACKAGE (50090-7190-0)
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204028 ANDA Preferred Pharmaceuticals Inc. 68788-8760 68788-8760-1 100 TABLET, EXTENDED RELEASE in 1 PACKAGE (68788-8760-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Jun 29, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Jun 29, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Dec 7, 2023TE:ABRLD:No

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