Clinisol

Basic Information

Product Name

Clinisol

FDA Product Code

0338-0502

Regulatory Information

NDC Product Code

0338-0502

Application Number

ANDA020512

Marketing Category

C73584

Effective Date

June 1, 2018

Territorial Authority

USA

FDA Title

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package Not for Direct Infusion in VIAFLEX Plastic Container

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LYSINE ACETATE

Quantity: 1.18 g in 100 mL

Code: TTL6G7LIWZ

Class Code: ACTIM

LEUCINE

Quantity: 1.04 g in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

PHENYLALANINE

Quantity: 1.04 g in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

VALINE

Quantity: 960 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

METHIONINE

Quantity: 749 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

HISTIDINE

Quantity: 894 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

ISOLEUCINE

Quantity: 749 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

ALANINE

Quantity: 2.17 g in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

TRYPTOPHAN

Quantity: 250 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

ARGININE

Quantity: 1.47 g in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

SERINE

Quantity: 592 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

PROLINE

Quantity: 894 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

GLYCINE

Quantity: 1.04 g in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

GLUTAMIC ACID

Quantity: 749 mg in 100 mL

Code: 3KX376GY7L

Class Code: ACTIB

TYROSINE

Quantity: 39 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

ASPARTIC ACID

Quantity: 434 mg in 100 mL

Code: 30KYC7MIAI

Class Code: ACTIB

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

THREONINE

Quantity: 749 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

Active Moieties

LYSINE

Code: K3Z4F929H6

PHENYLALANINE

Code: 47E5O17Y3R

ISOLEUCINE

Code: 04Y7590D77

VALINE

Code: HG18B9YRS7

LEUCINE

Code: GMW67QNF9C

THREONINE

Code: 2ZD004190S

METHIONINE

Code: AE28F7PNPL

TRYPTOPHAN

Code: 8DUH1N11BX

ARGININE

Code: 94ZLA3W45F

HISTIDINE

Code: 4QD397987E

TYROSINE

Code: 42HK56048U

ALANINE

Code: OF5P57N2ZX

GLYCINE

Code: TE7660XO1C

SERINE

Code: 452VLY9402

ASPARTIC ACID

Code: 30KYC7MIAI

PROLINE

Code: 9DLQ4CIU6V

GLUTAMIC ACID

Code: 3KX376GY7L

Basic Information

Regulatory Information

Company Information

Active Ingredients

ACETIC ACID

WATER

Active Moieties

LYSINE

PHENYLALANINE

ISOLEUCINE

VALINE

LEUCINE

THREONINE

METHIONINE

TRYPTOPHAN

ARGININE

HISTIDINE

TYROSINE

ALANINE

GLYCINE

SERINE

ASPARTIC ACID

PROLINE

GLUTAMIC ACID