← FDA DRUG APPROVALS

FDA ANDA · ANDA206481

TENOFOVIR DISOPROXIL FUMARATE

tenofovir disoproxil fumarate tablets

Sponsor: CHARTWELL

APPLICATION
ANDA206481
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-31
LATEST ACTION
2019-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TENOFOVIR DISOPROXIL FUMARATEPrescription
TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2019-11-20Labeling · Supplement 3 · standardAP
2019-11-20Labeling · Supplement 1 · standardAP
2019-11-20Labeling · Supplement 4 · standardAP
2019-11-20Labeling · Supplement 2 · standardAP
2018-07-31UNKNOWN · Original · standardAP
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 →