APPLICATION
NDA020089
TYPE
NDA
ORIGINAL APPROVAL
1991-04-30
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZOVIRAX · ReferenceDiscontinued
ACYCLOVIR 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOVIRAX · ReferenceDiscontinued
ACYCLOVIR 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-07-12Manufacturing (CMC) · Supplement 14 · standardAP
2000-03-15Labeling · Supplement 12 · standardAP
1999-06-10Manufacturing (CMC) · Supplement 13 · standardAP
1997-05-29Labeling · Supplement 11 · standardAP
1997-01-08Labeling · Supplement 10 · standardAP
1996-10-29Manufacturing (CMC) · Supplement 9 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 5 · standardAP
1995-05-31Manufacturing (CMC) · Supplement 8 · standardAP
1995-04-12Labeling · Supplement 7 · standardAP
1994-04-14Labeling · Supplement 4 · standardAP
1993-11-09Manufacturing (CMC) · Supplement 3 · standardAP
1993-04-22Labeling · Supplement 1AP
1991-04-30Type 3 - New Dosage Form · Original · standardAP
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.
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