← FDA DRUG APPROVALS

FDA ANDA · ANDA020512

CLINISOL

lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, tyrosine

Sponsor: BAXTER HLTHCARE

APPLICATION
ANDA020512
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-30
LATEST ACTION
2003-12-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINERPrescription
AMINO ACIDS 15% (15GM/100ML) · INJECTABLE · INJECTION

Approval history

2003-12-04Labeling · Supplement 7AP
2001-02-28Labeling · Supplement 5AP
2000-01-28Manufacturing (CMC) · Supplement 4 · standardAP
1999-07-30Manufacturing (CMC) · Supplement 3 · standardAP
1999-07-01Manufacturing (CMC) · Supplement 1 · standardAP
1999-06-11Manufacturing (CMC) · Supplement 2 · standardAP
1996-08-30Type 5 - New Formulation or New Manufacturer · 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 →