← FDA DRUG APPROVALS

FDA NDA · NDA019981

ULTRATAG RBC

kit for the preparation of technetium tc 99m red blood cells

Sponsor: CURIUM

APPLICATION
NDA019981
TYPE
NDA
ORIGINAL APPROVAL
1991-06-10
LATEST ACTION
2014-09-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ULTRATAG · ReferencePrescription
TECHNETIUM TC-99M RED BLOOD CELL KIT N/A · INJECTABLE · INJECTION

Approval history

2014-09-09Manufacturing (CMC) · Supplement 9 · standardAP
2000-04-18Manufacturing (CMC) · Supplement 5 · standardAP
1998-04-08Manufacturing (CMC) · Supplement 4 · standardAP
1998-01-23Labeling · Supplement 3 · standardAP
1993-09-30Manufacturing (CMC) · Supplement 2 · standardAP
1992-08-25Manufacturing (CMC) · Supplement 1 · standardAP
1991-06-10Type 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 →