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FDA NDA · NDA021821

TYGACIL

tigecycline

Sponsor: PF PRISM CV

APPLICATION
NDA021821
TYPE
NDA
ORIGINAL APPROVAL
2005-06-15
LATEST ACTION
2025-03-31
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TYGACIL · ReferencePrescription
TIGECYCLINE 50MG/VIAL · POWDER · INTRAVENOUS

Approval history

2025-03-31Labeling · Supplement 56 · standard — Label ↗AP
2020-06-23Labeling · Supplement 49 · standard — Label ↗AP
2020-01-16Labeling · Supplement 48 · standard — Label ↗AP
2018-04-16Labeling · Supplement 45 · standard — Label ↗AP
2016-06-29Labeling · Supplement 42 · standard — Label ↗AP
2016-05-31Labeling · Supplement 39 · standard — Label ↗AP
2016-01-19Labeling · Supplement 43 · standard — Label ↗AP
2014-01-09Manufacturing (CMC) · Supplement 36 · priorityAP
2013-09-26Labeling · Supplement 26 · unknown — Label ↗AP
2013-09-26Labeling · Supplement 31 · standard — Label ↗AP
2013-05-23Labeling · Supplement 37 · standard — Label ↗AP
2010-07-16Labeling · Supplement 27 · unknown — Label ↗AP
2010-07-16Labeling · Supplement 25 · unknown — Label ↗AP
2010-07-16Labeling · Supplement 21 · standard — Label ↗AP
2009-06-26Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2009-03-20Efficacy · Supplement 18 · unknown — Letter ↗AP
2009-03-20Efficacy · Supplement 17 · unknown — Label ↗AP
2009-03-20Efficacy · Supplement 13 · unknown — Letter ↗AP
2009-02-10Labeling · Supplement 16 · standard — Label ↗AP
2009-01-29Labeling · Supplement 14 · standard — Label ↗AP
2009-01-29Labeling · Supplement 19 · standard — Label ↗AP
2009-01-29Labeling · Supplement 11 · standard — Letter ↗AP
2007-05-18Labeling · Supplement 10 · standard — Letter ↗AP
2007-04-03Labeling · Supplement 7 · standard — Label ↗AP
2007-01-24Labeling · Supplement 6 · standard — Letter ↗AP
2006-07-12Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2006-07-12Labeling · Supplement 3 · standard — Letter ↗AP
2005-06-15Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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