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Glycine

1.5% GLYCINE IRRIGATION, USP

Approved
Approval ID

c10a4657-cf64-4a71-a247-363dd58993bc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 14, 2023

Manufacturers
FDA

ICU Medical Inc.

DUNS: 118380146

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GLYCINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0990-7974
Application NumberNDA018315
Product Classification
M
Marketing Category
C73594
G
Generic Name
GLYCINE
Product Specifications
Route of AdministrationIRRIGATION
Effective DateApril 14, 2023
FDA Product Classification

INGREDIENTS (2)

GLYCINEActive
Quantity: 1.5 g in 100 mL
Code: TE7660XO1C
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Glycine - FDA Drug Approval Details