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FDA NDA · NDA020984

RAPLON

Sponsor: ORGANON USA INC

APPLICATION
NDA020984
TYPE
NDA
ORIGINAL APPROVAL
1999-08-18
LATEST ACTION
2010-11-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

RAPLONDiscontinued
RAPACURONIUM BROMIDE 100MG/VIAL · INJECTABLE · INJECTION
RAPLONDiscontinued
RAPACURONIUM BROMIDE 200MG/VIAL · INJECTABLE · INJECTION

Approval history

2010-11-22Labeling · Supplement 3 · standard — Label ↗AP
2000-07-07Manufacturing (CMC) · Supplement 2 · standardAP
2000-01-19Manufacturing (CMC) · Supplement 1 · standardAP
1999-08-18Type 1 - New Molecular Entity · Original · standard — Letter ↗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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