← FDA DRUG APPROVALS

FDA NDA · NDA204311

ABACAVIR SULFATE AND LAMIVUDINE

Sponsor: PHARMOBEDIENT

APPLICATION
NDA204311
TYPE
NDA
ORIGINAL APPROVAL
2023-12-22
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

ABACAVIR SULFATE AND LAMIVUDINE · ReferenceDiscontinued
ABACAVIR SULFATE EQ 60MG BASE, LAMIVUDINE 30MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2023-12-22Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →