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FDA NDA · NDA203585

SYNRIBO

Sponsor: TEVA PHARMS INTL

APPLICATION
NDA203585
TYPE
NDA
ORIGINAL APPROVAL
2012-10-26
LATEST ACTION
2021-05-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

SYNRIBO · ReferenceDiscontinued
OMACETAXINE MEPESUCCINATE 3.5MG/VIAL · POWDER · SUBCUTANEOUS

Approval history

2021-05-12Labeling · Supplement 8 · standard — Letter ↗AP
2019-11-26Labeling · Supplement 7 · standard — Letter ↗AP
2019-01-23Labeling · Supplement 6 · standard — Label ↗AP
2017-06-21Labeling · Supplement 5 · standard — Letter ↗AP
2016-06-13Labeling · Supplement 4 · standard — Label ↗AP
2014-05-01Labeling · Supplement 3 · standard — Label ↗AP
2014-02-10Efficacy · Supplement 1 · standard — Label ↗AP
2013-11-22Manufacturing (CMC) · Supplement 2 · standardAP
2012-10-26Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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