← FDA DRUG APPROVALS

FDA ANDA · ANDA202459

ACYCLOVIR

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA202459
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-03
LATEST ACTION
2015-11-20
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

ACYCLOVIRPrescription
ACYCLOVIR 5% · OINTMENT · TOPICAL

Approval history

2015-11-20Manufacturing (CMC) · Supplement 3 · unknownAP
2013-05-17Manufacturing (CMC) · Supplement 1 · unknownAP
2013-04-03UNKNOWN · OriginalLetterAP
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 →