← FDA DRUG APPROVALS

FDA ANDA · ANDA204805

DESVENLAFAXINE

Sponsor: PLATINUM

APPLICATION
ANDA204805
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-07
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-17Labeling · Supplement 2 · standardAP
2019-10-25Manufacturing (CMC) · Supplement 1AP
2019-05-07UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →