← FDA DRUG APPROVALS

FDA ANDA · ANDA209672

VALGANCICLOVIR HYDROCHLORIDE

Sponsor: CIPLA

APPLICATION
ANDA209672
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-09
LATEST ACTION
2022-06-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VALGANCICLOVIR HYDROCHLORIDEDiscontinued
VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE · TABLET · ORAL

Approval history

2022-06-06Labeling · Supplement 5 · standardAP
2022-06-06Labeling · Supplement 3 · standardAP
2018-11-09UNKNOWN · 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 →