← FDA DRUG APPROVALS

FDA NDA · NDA021338

IONSYS

Sponsor: THE MEDICINES CO

APPLICATION
NDA021338
TYPE
NDA
ORIGINAL APPROVAL
2006-05-22
LATEST ACTION
2018-10-03
ROUTE
IONTOPHORESIS, TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Discontinued

Products

IONSYS · ReferenceDiscontinued
FENTANYL HYDROCHLORIDE EQ 40MCG BASE/ACTIVATION · SYSTEM · IONTOPHORESIS, TRANSDERMAL

Approval history

2018-10-03REMS · Supplement 10AP
2017-03-29REMS · Supplement 9 — Letter ↗AP
2016-12-16Labeling · Supplement 7 · standard — Letter ↗AP
2015-11-12REMS · Supplement 6 — Letter ↗AP
2015-04-30Efficacy · Supplement 5 · standard — Letter ↗AP
2006-05-22Type 3 - New Dosage Form · Original · standard — 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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