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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 204172

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NDA 204172 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic Pharms Ltd, Casi Pharms Inc, Hikma, Intellipharmaceutics, Lupin Ltd, Mylan, Yichang Humanwell, and Zydus Pharms, and is included in ten NDAs. It is available from fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 204172
Tradename:DESVENLAFAXINE SUCCINATE
Applicant:Lupin Ltd
Ingredient:desvenlafaxine succinate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204172 ANDA Direct_Rx 61919-882 61919-882-28 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-882-28)
DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204172 ANDA Lupin Pharmaceuticals, Inc. 68180-592 68180-592-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-02)

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

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