FDA NDA · NDA022011

TYZEKA

Sponsor: NOVARTIS

APPLICATION

NDA022011

TYPE

NDA

ORIGINAL APPROVAL

2006-10-25

LATEST ACTION

2018-12-27

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

TYZEKA · ReferenceDiscontinued

TELBIVUDINE 600MG · TABLET · ORAL

2018-12-27Labeling · Supplement 22 · standard — Label ↗AP

2018-03-28Labeling · Supplement 21 · standard — Letter ↗AP

2015-12-11Manufacturing (CMC) · Supplement 17 · standardAP

2013-12-06Manufacturing (CMC) · Supplement 16 · standardAP

2013-01-28Efficacy · Supplement 10 · standard — Label ↗AP

2013-01-28Efficacy · Supplement 13 · standard — Letter ↗AP

2011-12-23Labeling · Supplement 12 · standard — Letter ↗AP

2011-05-05REMS · Supplement 11 — Letter ↗AP

2011-03-29Labeling · Supplement 9 · 901 required — Label ↗AP

2010-09-10Labeling · Supplement 6 · unknown — Letter ↗AP

2010-03-04Labeling · Supplement 3 · standard — Letter ↗AP

2009-05-08Labeling · Supplement 2 · standard — Letter ↗AP

2009-01-23Efficacy · Supplement 1 · standard — Label ↗AP

2006-10-25Type 1 - New Molecular Entity · Original · standard — Label ↗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.

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