← FDA DRUG APPROVALS

FDA NDA · NDA020544

JADELLE

Sponsor: POPULATION COUNCIL

APPLICATION
NDA020544
TYPE
NDA
ORIGINAL APPROVAL
1996-11-01
LATEST ACTION
2016-12-20
ROUTE
IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Discontinued

Products

JADELLE · ReferenceDiscontinued
LEVONORGESTREL 75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · IMPLANT · IMPLANTATION

Approval history

2016-12-20Labeling · Supplement 10 · standard — Letter ↗AP
2002-11-22Efficacy · Supplement 3 · standard — Label ↗AP
2000-01-05Manufacturing (CMC) · Supplement 2 · standardAP
1998-11-05Manufacturing (CMC) · Supplement 1 · standardAP
1996-11-01Type 3 - New Dosage Form · Original · standardAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →