MedPath
FDA Product

CLINIMIX

Product approved by U.S. Food and Drug Administration (US)

Basic Information

CLINIMIX

0338-0198

Regulatory Information

0338-0198

NDA020734

C73594

April 13, 2021

USA

These highlights do not include all the information needed to use CLINIMIX safely and effectively. See full prescribing information for CLINIMIX. CLINIMIX (amino acids in dextrose) injection, for intravenous use Initial U.S. Approval: 1997

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

005083209

Active Ingredients

PHENYLALANINE

Quantity: 336 mg in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

LEUCINE

Quantity: 438 mg in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

LYSINE

Quantity: 348 mg in 100 mL

Code: K3Z4F929H6

Class Code: ACTIB

THREONINE

Quantity: 252 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

VALINE

Quantity: 348 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

HISTIDINE

Quantity: 288 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

ISOLEUCINE

Quantity: 360 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

METHIONINE

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

ALANINE

Quantity: 1242 mg in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

TRYPTOPHAN

Quantity: 108 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

GLYCINE

Quantity: 618 mg in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

DEXTROSE

Quantity: 5 g in 100 mL

Code: IY9XDZ35W2

Class Code: ACTIB

ARGININE

Quantity: 690 mg in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

PROLINE

Quantity: 408 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

TYROSINE

Quantity: 24 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

NITROGEN

Code: N762921K75

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

SERINE

Quantity: 300 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

LEUCINE

Code: GMW67QNF9C

PHENYLALANINE

Code: 47E5O17Y3R

LYSINE

Code: K3Z4F929H6

METHIONINE

Code: AE28F7PNPL

ISOLEUCINE

Code: 04Y7590D77

VALINE

Code: HG18B9YRS7

HISTIDINE

Code: 4QD397987E

THREONINE

Code: 2ZD004190S

GLYCINE

Code: TE7660XO1C

TRYPTOPHAN

Code: 8DUH1N11BX

ALANINE

Code: OF5P57N2ZX

PROLINE

Code: 9DLQ4CIU6V

TYROSINE

Code: 42HK56048U

DEXTROSE

Code: IY9XDZ35W2

ARGININE

Code: 94ZLA3W45F

SERINE

Code: 452VLY9402

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy