← FDA DRUG APPROVALS

FDA NDA · NDA020678

CLINIMIX E

leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020678
TYPE
NDA
ORIGINAL APPROVAL
1997-03-26
LATEST ACTION
2021-04-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 5%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 20GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 340MG/100ML, SODIUM CHLORIDE 59MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 5%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 10GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 340MG/100ML, SODIUM CHLORIDE 59MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 4.25%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 4.25%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 25GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 2.75%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 10GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 217MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 5%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 25GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 340MG/100ML, SODIUM CHLORIDE 59MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 5%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 15GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 340MG/100ML, SODIUM CHLORIDE 59MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 4.25%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 10GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 5%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 35GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 340MG/100ML, SODIUM CHLORIDE 59MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 2.75%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 25GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 217MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 4.25%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 20GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
AMINO ACIDS 2.75%, CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 217MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION

Approval history

2021-04-13Labeling · Supplement 42 · standard — Letter ↗AP
2018-10-12Manufacturing (CMC) · Supplement 38 · standard — Label ↗AP
2016-09-27Labeling · Supplement 27 · standard — Label ↗AP
2015-09-01Manufacturing (CMC) · Supplement 31 · standardAP
2015-02-09Manufacturing (CMC) · Supplement 30 · standardAP
2014-09-30Manufacturing (CMC) · Supplement 29 · standardAP
2014-09-15Manufacturing (CMC) · Supplement 24 · standardAP
2014-08-29Manufacturing (CMC) · Supplement 28 · standardAP
2009-11-02Labeling · Supplement 21 · standard — Letter ↗AP
2004-01-23Labeling · Supplement 14 · standard — Letter ↗AP
2003-05-21Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2002-07-25Labeling · Supplement 11 · standard — Letter ↗AP
2002-07-25Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2002-02-15Manufacturing (CMC) · Supplement 9 · standardAP
2001-04-04Manufacturing (CMC) · Supplement 7 · standardAP
2000-10-19Manufacturing (CMC) · Supplement 6 · standardAP
2000-04-12Efficacy · Supplement 3 · standard — Review ↗AP
2000-03-24Manufacturing (CMC) · Supplement 5 · standardAP
2000-02-25Manufacturing (CMC) · Supplement 4 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 2 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 1 · standardAP
1997-03-26Type 4 - New Combination · Original · standard — Review ↗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.

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 →