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FDA NDA · NDA020105

TRIOSTAT

Sponsor: PH HEALTH

APPLICATION
NDA020105
TYPE
NDA
ORIGINAL APPROVAL
1991-12-31
LATEST ACTION
2002-05-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TRIOSTAT · ReferenceDiscontinued
LIOTHYRONINE SODIUM EQ 0.01MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2002-05-20Labeling · Supplement 2 · standard — Letter ↗AP
2000-06-09Manufacturing (CMC) · Supplement 1 · priorityAP
1991-12-31Type 3 - New Dosage Form · Original · priorityAP
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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