← FDA DRUG APPROVALS

FDA NDA · NDA020333

AGRYLIN

anagrelide hydrochloride

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA020333
TYPE
NDA
ORIGINAL APPROVAL
1997-03-14
LATEST ACTION
2021-10-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

AGRYLINPrescription
ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
AGRYLIN · ReferenceDiscontinued
ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2021-10-13Labeling · Supplement 27 · standard — Letter ↗AP
2020-02-28Labeling · Supplement 26 · standard — Letter ↗AP
2018-12-19Labeling · Supplement 25 · standard — Label ↗AP
2018-03-20Labeling · Supplement 24 · standard — Label ↗AP
2015-07-14Labeling · Supplement 23 · standard — Label ↗AP
2014-10-30Labeling · Supplement 22 · standard — Label ↗AP
2014-02-07Labeling · Supplement 21 · standard — Letter ↗AP
2013-07-17Labeling · Supplement 20 · standard — Letter ↗AP
2011-11-22Labeling · Supplement 19 · standard — Label ↗AP
2011-01-31Labeling · Supplement 17 · unknown — Label ↗AP
2010-06-30Labeling · Supplement 16 · unknown — Letter ↗AP
2009-07-09Labeling · Supplement 15 · standard — Letter ↗AP
2008-06-17Labeling · Supplement 13 · standard — Review ↗AP
2004-12-17Labeling · Supplement 10 · standard — Label ↗AP
2004-12-10Efficacy · Supplement 8 · priority — Letter ↗AP
2004-12-10Labeling · Supplement 9 · standard — Label ↗AP
2002-10-10Manufacturing (CMC) · Supplement 7 · priorityAP
2002-03-15Manufacturing (CMC) · Supplement 6 · priorityAP
2000-11-03Manufacturing (CMC) · Supplement 5 · priorityAP
2000-03-13Labeling · Supplement 4 · standardAP
1999-08-19Manufacturing (CMC) · Supplement 3 · priorityAP
1998-12-16Efficacy · Supplement 2 · standard — Label ↗AP
1997-11-07Manufacturing (CMC) · Supplement 1 · priorityAP
1997-03-14Type 1 - New Molecular Entity · Original · priority — Pediatric Written Request ↗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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