← FDA DRUG APPROVALS

FDA NDA · NDA020107

NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020107
TYPE
NDA
ORIGINAL APPROVAL
1993-02-05
LATEST ACTION
1993-02-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 15% (15GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

1993-02-05Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →