APPLICATION
ANDA204065
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-29
LATEST ACTION
2024-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-08-16Labeling · Supplement 10 · standardAP
2024-08-16Labeling · Supplement 13 · standardAP
2019-11-29Labeling · Supplement 5 · standardAP
2019-11-29Labeling · Supplement 2 · standardAP
2016-07-29UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.