ProSol

Basic Information

Product Name

ProSol

FDA Product Code

0338-0499

Regulatory Information

NDC Product Code

0338-0499

Application Number

NDA020849

Marketing Category

C73594

Effective Date

October 7, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use PROSOL safely and effectively. See full prescribing information for PROSOL. Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

VALINE

Quantity: 1.44 g in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

LYSINE ACETATE

Quantity: 1.35 g in 100 mL

Code: TTL6G7LIWZ

Class Code: ACTIM

PHENYLALANINE

Quantity: 1 g in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

ISOLEUCINE

Quantity: 1.08 g in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

METHIONINE

Quantity: 760 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

GLUTAMIC ACID

Quantity: 1.02 g in 100 mL

Code: 3KX376GY7L

Class Code: ACTIB

SERINE

Quantity: 1.02 g in 100 mL

Code: 452VLY9402

Class Code: ACTIB

ASPARTIC ACID

Quantity: 600 mg in 100 mL

Code: 30KYC7MIAI

Class Code: ACTIB

TYROSINE

Quantity: 50 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

NITROGEN

Code: N762921K75

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

HISTIDINE

Quantity: 1.18 g in 100 mL

Code: 4QD397987E

Class Code: ACTIB

LEUCINE

Quantity: 1.08 g in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

THREONINE

Quantity: 980 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

TRYPTOPHAN

Quantity: 320 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

ALANINE

Quantity: 2.76 g in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

GLYCINE

Quantity: 2.06 g in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

ARGININE

Quantity: 1.96 g in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

PROLINE

Quantity: 1.34 g in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

Active Moieties

PHENYLALANINE

Code: 47E5O17Y3R

TRYPTOPHAN

Code: 8DUH1N11BX

ALANINE

Code: OF5P57N2ZX

VALINE

Code: HG18B9YRS7

LYSINE

Code: K3Z4F929H6

HISTIDINE

Code: 4QD397987E

METHIONINE

Code: AE28F7PNPL

GLYCINE

Code: TE7660XO1C

ISOLEUCINE

Code: 04Y7590D77

LEUCINE

Code: GMW67QNF9C

THREONINE

Code: 2ZD004190S

ARGININE

Code: 94ZLA3W45F

PROLINE

Code: 9DLQ4CIU6V

SERINE

Code: 452VLY9402

GLUTAMIC ACID

Code: 3KX376GY7L

ASPARTIC ACID

Code: 30KYC7MIAI

TYROSINE

Code: 42HK56048U

Basic Information

Regulatory Information

Company Information

Active Ingredients

NITROGEN

ACETIC ACID

WATER

Active Moieties

PHENYLALANINE

TRYPTOPHAN

ALANINE

VALINE

LYSINE

HISTIDINE

METHIONINE

GLYCINE

ISOLEUCINE

LEUCINE

THREONINE

ARGININE

PROLINE

SERINE

GLUTAMIC ACID

ASPARTIC ACID

TYROSINE