← FDA DRUG APPROVALS

FDA ANDA · ANDA074930

ACYCLOVIR

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA074930
TYPE
ANDA
ORIGINAL APPROVAL
1998-05-13
LATEST ACTION
2024-03-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ACYCLOVIR SODIUMPrescription
ACYCLOVIR SODIUM EQ 50MG BASE/ML · INJECTABLE · INJECTION

Approval history

2024-03-28Labeling · Supplement 12 · standardAP
2005-01-20Labeling · Supplement 4AP
2002-05-24Labeling · Supplement 2AP
2000-05-10Labeling · Supplement 1AP
1998-05-13OriginalReviewAP
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 →