← FDA DRUG APPROVALS

FDA NDA · NDA022311

MOZOBIL

plerixafor

Sponsor: GENZYME

APPLICATION
NDA022311
TYPE
NDA
ORIGINAL APPROVAL
2008-12-15
LATEST ACTION
2023-09-21
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MOZOBIL · ReferencePrescription
PLERIXAFOR 24MG/1.2ML (20MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2023-09-21Labeling · Supplement 23 · standard — Letter ↗AP
2020-08-19Labeling · Supplement 22 · standard — Letter ↗AP
2019-05-30Labeling · Supplement 20 · standard — Label ↗AP
2017-12-01Labeling · Supplement 18 · standard — Label ↗AP
2016-05-12Manufacturing (CMC) · Supplement 17 · priorityAP
2015-08-04Labeling · Supplement 16 · standard — Label ↗AP
2014-12-04Labeling · Supplement 15 · standard — Label ↗AP
2013-11-12Manufacturing (CMC) · Supplement 14 · priorityAP
2013-06-04Labeling · Supplement 13 · standard — Label ↗AP
2013-02-26Manufacturing (CMC) · Supplement 12 · priorityAP
2010-06-14Labeling · Supplement 1 · unknown — Label ↗AP
2008-12-15Type 1 - New Molecular Entity · Original · priority — Review ↗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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