← FDA DRUG APPROVALS

FDA NDA · NDA022142

SYMFI

efavirenz, lamivudine and tenofovir disoproxil fumarate

Sponsor: MYLAN LABS LTD

APPLICATION
NDA022142
TYPE
NDA
ORIGINAL APPROVAL
2018-03-22
LATEST ACTION
2019-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SYMFI · ReferencePrescription
EFAVIRENZ 600MG, LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2019-10-29Labeling · Supplement 37 · standard — Letter ↗AP
2018-03-22Type 4 - New Combination · Original · priority — 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 →