← FDA DRUG APPROVALS

FDA ANDA · ANDA202659

SILDENAFIL

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA202659
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-11
LATEST ACTION
2018-06-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 50MG BASE · TABLET · ORAL
SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 100MG BASE · TABLET · ORAL
SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 25MG BASE · TABLET · ORAL

Approval history

2018-06-11UNKNOWN · OriginalAP
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 →