← FDA DRUG APPROVALS

FDA ANDA · ANDA214019

DAPSONE

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
ANDA214019
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-08
LATEST ACTION
2024-05-08
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

DAPSONEPrescription
DAPSONE 7.5% · GEL · TOPICAL

Approval history

2024-05-08UNKNOWN · 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 →