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FDA NDA · NDA019909

ZOVIRAX

Sponsor: PHARMOBEDIENT

APPLICATION
NDA019909
TYPE
NDA
ORIGINAL APPROVAL
1989-12-22
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

ZOVIRAX · ReferenceDiscontinued
ACYCLOVIR 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2025-11-12Labeling · Supplement 28 · standard — Label ↗AP
2016-04-18Manufacturing (CMC) · Supplement 23 · standardAP
2008-08-08Labeling · Supplement 22 · standard — Letter ↗AP
2005-12-09Labeling · Supplement 20 · standard — Letter ↗AP
2004-05-19Labeling · Supplement 19 · standard — Label ↗AP
2001-11-14Labeling · Supplement 17 · standard — Label ↗AP
2001-11-14Labeling · Supplement 16 · standard — Label ↗AP
2000-07-12Manufacturing (CMC) · Supplement 15 · standardAP
2000-03-15Labeling · Supplement 14 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 13 · standardAP
1997-05-29Labeling · Supplement 12 · standardAP
1997-01-08Labeling · Supplement 11 · standardAP
1996-10-29Manufacturing (CMC) · Supplement 10 · standardAP
1995-04-12Labeling · Supplement 8 · standardAP
1994-04-14Labeling · Supplement 6 · standardAP
1993-11-09Manufacturing (CMC) · Supplement 5 · standardAP
1993-04-22Labeling · Supplement 4AP
1992-02-26Efficacy · Supplement 3 — Review ↗AP
1991-04-30Labeling · Supplement 2AP
1990-04-26Labeling · Supplement 1AP
1989-12-22Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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