← FDA DRUG APPROVALS

FDA ANDA · ANDA205988

VARDENAFIL

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA205988
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-10
LATEST ACTION
2023-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

VARDENAFIL HYDROCHLORIDEPrescription
VARDENAFIL HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2023-10-30Labeling · Supplement 7 · standardAP
2020-03-10UNKNOWN · 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 →