FDA NDA · NDA022154

TYZEKA

Sponsor: NOVARTIS

APPLICATION

NDA022154

TYPE

NDA

ORIGINAL APPROVAL

2009-04-28

LATEST ACTION

2018-12-27

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

TYZEKADiscontinued

TELBIVUDINE 100MG/5ML · SOLUTION · ORAL

2018-12-27Labeling · Supplement 19 · standard — Label ↗AP

2018-03-28Labeling · Supplement 18 · standard — Letter ↗AP

2014-01-30Manufacturing (CMC) · Supplement 14 · standardAP

2013-12-06Manufacturing (CMC) · Supplement 13 · standardAP

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

2011-12-23Labeling · Supplement 9 · standard — Label ↗AP

2011-05-05REMS · Supplement 8 — Letter ↗AP

2011-03-29Labeling · Supplement 6 · 901 required — Label ↗AP

2010-09-10Labeling · Supplement 3 · unknown — Label ↗AP

2010-03-04Labeling · Supplement 1 · standard — Letter ↗AP

2009-04-28Type 3 - New Dosage Form · 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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