MedPath
FDA Product

CLINIMIX

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

Basic Information

CLINIMIX

0338-1101

Regulatory Information

0338-1101

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

LEUCINE

Quantity: 365 mg in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

METHIONINE

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

TRYPTOPHAN

Quantity: 90 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

HISTIDINE

Quantity: 240 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

THREONINE

Quantity: 210 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

ALANINE

Quantity: 1035 mg in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

GLYCINE

Quantity: 515 mg in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

PROLINE

Quantity: 340 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

TYROSINE

Quantity: 20 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

DEXTROSE

Quantity: 20 g in 100 mL

Code: IY9XDZ35W2

Class Code: ACTIB

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

NITROGEN

Code: N762921K75

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

VALINE

Quantity: 290 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

PHENYLALANINE

Quantity: 280 mg in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

LYSINE

Quantity: 290 mg in 100 mL

Code: K3Z4F929H6

Class Code: ACTIB

ISOLEUCINE

Quantity: 300 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

ARGININE

Quantity: 575 mg in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

SERINE

Quantity: 250 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

Active Moieties

PHENYLALANINE

Code: 47E5O17Y3R

LYSINE

Code: K3Z4F929H6

LEUCINE

Code: GMW67QNF9C

METHIONINE

Code: AE28F7PNPL

VALINE

Code: HG18B9YRS7

ISOLEUCINE

Code: 04Y7590D77

TRYPTOPHAN

Code: 8DUH1N11BX

HISTIDINE

Code: 4QD397987E

ALANINE

Code: OF5P57N2ZX

THREONINE

Code: 2ZD004190S

TYROSINE

Code: 42HK56048U

GLYCINE

Code: TE7660XO1C

SERINE

Code: 452VLY9402

DEXTROSE

Code: IY9XDZ35W2

ARGININE

Code: 94ZLA3W45F

PROLINE

Code: 9DLQ4CIU6V

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

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