APPLICATION
NDA018828
TYPE
NDA
ORIGINAL APPROVAL
1985-01-25
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ZOVIRAX · ReferenceDiscontinued
ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2000-07-12Manufacturing (CMC) · Supplement 25 · priorityAP
2000-03-15Labeling · Supplement 24 · standardAP
2000-03-15Labeling · Supplement 22 · standardAP
1999-02-18Manufacturing (CMC) · Supplement 23 · priorityAP
1997-11-04Manufacturing (CMC) · Supplement 21 · priorityAP
1997-05-29Labeling · Supplement 20 · standardAP
1997-01-08Labeling · Supplement 19 · standardAP
1996-10-29Manufacturing (CMC) · Supplement 18 · priorityAP
1995-04-12Labeling · Supplement 17 · standardAP
1994-04-14Labeling · Supplement 14 · standardAP
1993-11-09Manufacturing (CMC) · Supplement 13 · priorityAP
1993-04-22Labeling · Supplement 5AP
1993-04-22Labeling · Supplement 12AP
1991-04-30Labeling · Supplement 9AP
1990-04-20Efficacy · Supplement 7AP
1989-12-22Efficacy · Supplement 1AP
1988-10-24Labeling · Supplement 8AP
1988-10-24Manufacturing (CMC) · Supplement 6 · priorityAP
1987-10-29Labeling · Supplement 3AP
1986-12-02Labeling · Supplement 2AP
1985-01-25Type 3 - New Dosage Form · Original · priorityAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.