← FDA DRUG APPROVALS

FDA ANDA · ANDA065203

NYSTATIN

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA065203
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-15
LATEST ACTION
2006-02-13
ROUTE
TOPICAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · POWDER · TOPICAL

Approval history

2006-02-13Labeling · Supplement 4AP
2004-07-15OriginalAP
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 →