FDA NDA · NDA020629

DENAVIR

penciclovir

Sponsor: MYLAN

APPLICATION

NDA020629

TYPE

NDA

ORIGINAL APPROVAL

1996-09-24

LATEST ACTION

2018-11-21

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Prescription

Products

DENAVIR · ReferencePrescription

PENCICLOVIR 1% · CREAM · TOPICAL

2018-11-21Labeling · Supplement 19 · standard — Label ↗AP

2015-02-09Manufacturing (CMC) · Supplement 17 · standardAP

2013-09-11Labeling · Supplement 16 · standard — Label ↗AP

2003-10-10Efficacy · Supplement 8 · standard — Label ↗AP

2003-05-16Labeling · Supplement 9 · standard — Label ↗AP

2001-08-18Manufacturing (CMC) · Supplement 5 · standardAP

1998-12-22Manufacturing (CMC) · Supplement 3 · standardAP

1998-09-22Manufacturing (CMC) · Supplement 1 · standardAP

1996-09-24Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.