← FDA DRUG APPROVALS

FDA ANDA · ANDA206401

SILDENAFIL CITRATE

sildenafil

Sponsor: AJANTA PHARMA LTD

APPLICATION
ANDA206401
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-12
LATEST ACTION
2018-10-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2018-10-12UNKNOWN · Original · standardAP
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 →