← FDA DRUG APPROVALS

FDA NDA · NDA021344

FASLODEX

fulvestrant

Sponsor: ASTRAZENECA

APPLICATION
NDA021344
TYPE
NDA
ORIGINAL APPROVAL
2002-04-25
LATEST ACTION
2021-01-19
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

FASLODEX · ReferencePrescription
FULVESTRANT 250MG/5ML (50MG/ML) · SOLUTION · INTRAMUSCULAR
FASLODEX · ReferenceDiscontinued
FULVESTRANT 125MG/2.5ML (50MG/ML) · SOLUTION · INTRAMUSCULAR

Approval history

2021-01-19Labeling · Supplement 44 · standard — Letter ↗AP
2020-07-28Efficacy · Supplement 42 · standard — Letter ↗AP
2020-05-13Efficacy · Supplement 41 · standard — Label ↗AP
2019-11-21Efficacy · Supplement 38 · standard — Label ↗AP
2019-05-20Labeling · Supplement 39 · standard — Label ↗AP
2019-03-11Efficacy · Supplement 37 · priority — Label ↗AP
2018-07-05Efficacy · Supplement 36 · standard — Letter ↗AP
2017-11-14Efficacy · Supplement 35 · priority — Label ↗AP
2017-08-25Efficacy · Supplement 34 · standard — Letter ↗AP
2017-01-24Labeling · Supplement 33 · standard — Letter ↗AP
2016-10-31Manufacturing (CMC) · Supplement 28 · standardAP
2016-10-26Labeling · Supplement 31 · standard — Letter ↗AP
2016-07-12Labeling · Supplement 29 · standard — Letter ↗AP
2016-05-19Labeling · Supplement 27 · standard — Label ↗AP
2016-03-02Efficacy · Supplement 26 · standard — Review ↗AP
2016-03-01Labeling · Supplement 25 · standard — Label ↗AP
2014-08-25Manufacturing (CMC) · Supplement 24 · standardAP
2014-06-30Manufacturing (CMC) · Supplement 30 · standardAP
2013-10-08Manufacturing (CMC) · Supplement 21 · standardAP
2013-10-08Manufacturing (CMC) · Supplement 22 · standardAP
2012-11-09Efficacy · Supplement 20 · priority — Letter ↗AP
2012-11-09Labeling · Supplement 19 · standard — Label ↗AP
2012-07-13Labeling · Supplement 18 · standard — Label ↗AP
2011-09-26Labeling · Supplement 15 · unknown — Label ↗AP
2011-09-26Labeling · Supplement 14 · standard — Label ↗AP
2011-05-17Efficacy · Supplement 13 · priority — Pediatric Medical Review ↗AP
2010-09-09Efficacy · Supplement 12 · standard — Letter ↗AP
2010-09-09Labeling · Supplement 7 · standard — Letter ↗AP
2005-08-02Labeling · Supplement 4 · standard — Label ↗AP
2003-12-24Efficacy · Supplement 1 · standard — Label ↗AP
2002-04-25Type 1 - New Molecular Entity · Original · standard — Review ↗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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