← FDA DRUG APPROVALS

FDA ANDA · ANDA206430

VALRUBICIN INTRAVESICAL SOLUTION

Sponsor: HIKMA

APPLICATION
ANDA206430
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-19
LATEST ACTION
2019-04-19
ROUTE
INTRAVESICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VALRUBICINPrescription
VALRUBICIN 40MG/ML · SOLUTION · INTRAVESICAL

Approval history

2019-04-19UNKNOWN · 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 →