← FDA DRUG APPROVALS

FDA NDA · NDA022504

AXIRON

Sponsor: ELI LILLY AND CO

APPLICATION
NDA022504
TYPE
NDA
ORIGINAL APPROVAL
2010-11-23
LATEST ACTION
2017-07-13
ROUTE
TRANSDERMAL
DOSAGE FORM
SOLUTION, METERED
MARKETING STATUS
Discontinued

Products

AXIRON · ReferenceDiscontinued
TESTOSTERONE 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION, METERED · TRANSDERMAL

Approval history

2017-07-13Labeling · Supplement 16 · standard — Label ↗AP
2017-02-03Labeling · Supplement 13 · standard — Label ↗AP
2017-01-23REMS · Supplement 15 — Letter ↗AP
2016-10-25Labeling · Supplement 14 · standard — Letter ↗AP
2015-05-11Labeling · Supplement 12 · standard — Label ↗AP
2014-06-19Labeling · Supplement 11 · standard — Label ↗AP
2014-02-27Manufacturing (CMC) · Supplement 9 · standardAP
2014-01-15Manufacturing (CMC) · Supplement 7 · standardAP
2013-05-29Manufacturing (CMC) · Supplement 8 · standardAP
2011-12-22Labeling · Supplement 5 · standard — Review ↗AP
2011-03-31REMS · Supplement 2 — Label ↗AP
2010-11-23Type 3 - New Dosage Form · 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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