Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container, Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container, Clinimix E 2.75/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container

NDA 20678, held by Baxter Hlthcare. Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 20678 (Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container, Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container, Clinimix E 2.75/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Mar 26, 1997, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1997
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Apr 12, 2000	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 26, 1997	Original applicationNew combination · Standard review	Approved	Review

Products

12 strengths and forms


Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 2.75/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 4.25/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 4.25/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 4.25/20 Sulfite Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 4.25/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 5/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 5/15 Sulfite Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 5/20 Sulfite Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 5/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug
Clinimix E 5/35 Sulfite Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Apr 13, 2021	Supplement 42Labeling · Standard review	Approved	Label Letter
Oct 12, 2018	Supplement 38Manufacturing · Standard review	Approved	Label
Sep 27, 2016	Supplement 27Labeling · Standard review	Approved	Letter Label
Sep 1, 2015	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 9, 2015	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 30, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 15, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 29, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 2, 2009	Supplement 21Labeling · Standard review	Approved	Letter
Jan 23, 2004	Supplement 14Labeling · Standard review	Approved	Letter
May 21, 2003	Supplement 13Manufacturing · Standard review	Approved	Letter
Jul 25, 2002	Supplement 11Labeling · Standard review	Approved	Letter
Jul 25, 2002	Supplement 10Manufacturing · Standard review	Approved	Letter
Feb 15, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 4, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 19, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 24, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 25, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
May 25, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 15, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 26, 1997	Original applicationNew combination · Standard review	Approved	Review

Identifiers

Application: NDA 20678
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters