← FDA DRUG APPROVALS

FDA NDA · NDA021478

ACYCLOVIR

Sponsor: BAUSCH

APPLICATION
NDA021478
TYPE
NDA
ORIGINAL APPROVAL
2002-12-30
LATEST ACTION
2020-12-23
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ZOVIRAX · ReferencePrescription
ACYCLOVIR 5% · CREAM · TOPICAL

Approval history

2020-12-23Labeling · Supplement 10 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
2014-04-01Labeling · Supplement 7 · standard — Letter ↗AP
2004-01-23Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
2002-12-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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