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FDA Product

Premasol - sulfite-free (Amino Acid)

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

Basic Information

Premasol - sulfite-free (Amino Acid)

0338-1131

Regulatory Information

0338-1131

ANDA075880

C73584

August 4, 2022

USA

PREMASOL 10% - sulfite-free (amino acids) injection in VIAFLEX Plastic Container

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

005083209

Active Ingredients

GLYCINE

Quantity: 0.22 g in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

ASPARTIC ACID

Quantity: 0.19 g in 100 mL

Code: 30KYC7MIAI

Class Code: ACTIB

TAURINE

Quantity: 15 mg in 100 mL

Code: 1EQV5MLY3D

Class Code: ACTIB

CYSTEINE HYDROCHLORIDE

Quantity: 0.014 g in 100 mL

Code: ZT934N0X4W

Class Code: ACTIM

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

NITROGEN

Code: N762921K75

Class Code: IACT

LYSINE ACETATE

Quantity: 0.49 g in 100 mL

Code: TTL6G7LIWZ

Class Code: ACTIM

LEUCINE

Quantity: 0.84 g in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

ISOLEUCINE

Quantity: 0.49 g in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

VALINE

Quantity: 0.47 g in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

HISTIDINE

Quantity: 0.29 g in 100 mL

Code: 4QD397987E

Class Code: ACTIB

PHENYLALANINE

Quantity: 0.29 g in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

THREONINE

Quantity: 0.25 g in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

METHIONINE

Quantity: 0.20 g in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

TRYPTOPHAN

Quantity: 0.12 g in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

TYROSINE

Quantity: 0.14 g in 100 mL

Code: 42HK56048U

Class Code: ACTIB

ARGININE

Quantity: 0.73 g in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

PROLINE

Quantity: 0.41 g in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

ALANINE

Quantity: 0.32 g in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

GLUTAMIC ACID

Quantity: 0.30 g in 100 mL

Code: 3KX376GY7L

Class Code: ACTIB

SERINE

Quantity: 0.23 g in 100 mL

Code: 452VLY9402

Class Code: ACTIB

Active Moieties

LEUCINE

Code: GMW67QNF9C

VALINE

Code: HG18B9YRS7

ISOLEUCINE

Code: 04Y7590D77

LYSINE

Code: K3Z4F929H6

METHIONINE

Code: AE28F7PNPL

PHENYLALANINE

Code: 47E5O17Y3R

TYROSINE

Code: 42HK56048U

HISTIDINE

Code: 4QD397987E

SERINE

Code: 452VLY9402

THREONINE

Code: 2ZD004190S

PROLINE

Code: 9DLQ4CIU6V

ALANINE

Code: OF5P57N2ZX

GLUTAMIC ACID

Code: 3KX376GY7L

ASPARTIC ACID

Code: 30KYC7MIAI

TRYPTOPHAN

Code: 8DUH1N11BX

ARGININE

Code: 94ZLA3W45F

GLYCINE

Code: TE7660XO1C

TAURINE

Code: 1EQV5MLY3D

CYSTEINE

Code: K848JZ4886

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