← FDA DRUG APPROVALS

FDA NDA · NDA020363

FAMVIR

Sponsor: NOVARTIS

APPLICATION
NDA020363
TYPE
NDA
ORIGINAL APPROVAL
1994-06-29
LATEST ACTION
2018-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FAMVIR · ReferenceDiscontinued
FAMCICLOVIR 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FAMVIR · ReferenceDiscontinued
FAMCICLOVIR 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FAMVIR · ReferenceDiscontinued
FAMCICLOVIR 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-12-18Labeling · Supplement 50 · standard — Label ↗AP
2016-12-09Manufacturing (CMC) · Supplement 49 · standardAP
2016-11-01Manufacturing (CMC) · Supplement 48 · standardAP
2016-09-16Labeling · Supplement 47 · standard — Label ↗AP
2015-10-19Manufacturing (CMC) · Supplement 45 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 46 · standardAP
2015-05-14Manufacturing (CMC) · Supplement 44 · standardAP
2014-06-25Manufacturing (CMC) · Supplement 41 · standardAP
2013-04-24Labeling · Supplement 42 · standard — Label ↗AP
2012-02-09Labeling · Supplement 40 · standard — Label ↗AP
2012-02-09Efficacy · Supplement 38 · standard — Label ↗AP
2011-01-31Efficacy · Supplement 37 · standard — Label ↗AP
2009-12-24Efficacy · Supplement 36 · priority — Pediatric Written Request ↗AP
2008-12-22Labeling · Supplement 34 · standard — Letter ↗AP
2007-06-06Manufacturing (CMC) · Supplement 32AP
2006-07-28Efficacy · Supplement 27 · standard — Label ↗AP
2006-07-28Efficacy · Supplement 28 · unknown — Letter ↗AP
2006-02-22Labeling · Supplement 26 · standard — Label ↗AP
2002-08-06Manufacturing (CMC) · Supplement 20 · standardAP
2001-03-29Labeling · Supplement 19 · standard — Review ↗AP
1999-02-02Manufacturing (CMC) · Supplement 17 · standardAP
1998-06-12Labeling · Supplement 16 · standard — Letter ↗AP
1998-06-12Efficacy · Supplement 14 · standard — Letter ↗AP
1998-06-12Labeling · Supplement 10 · standard — Letter ↗AP
1998-03-26Manufacturing (CMC) · Supplement 15 · standardAP
1997-09-17Efficacy · Supplement 12 · standardAP
1997-07-15Labeling · Supplement 13 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 11 · standardAP
1997-01-13Labeling · Supplement 9 · standardAP
1996-07-29Labeling · Supplement 7 · standardAP
1996-07-29Labeling · Supplement 5 · standardAP
1996-04-26Labeling · Supplement 8 · standardAP
1995-12-11Efficacy · Supplement 4 · standardAP
1995-09-08Manufacturing (CMC) · Supplement 6 · standardAP
1994-12-27Manufacturing (CMC) · Supplement 1 · standardAP
1994-06-29Type 1 - New Molecular Entity · Original · standardAP
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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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