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Legend

Legend (hyaluronate sodium) Injectable Solution

Approved
Approval ID

fe08dc5c-e1d3-44ca-837b-4ede07402771

Product Type

PRESCRIPTION ANIMAL DRUG LABEL

Effective Date

May 2, 2025

Manufacturers
FDA

Boehringer Ingelheim Animal Health USA Inc

DUNS: 007134091

Products 1

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

hyaluronate sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0010-3141
Application NumberNADA140883
Product Classification
M
Marketing Category
C73593
G
Generic Name
hyaluronate sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 2, 2025
FDA Product Classification

INGREDIENTS (4)

hyaluronate sodiumActive
Quantity: 10 mg in 1 mL
Code: YSE9PPT4TH
Classification: ACTIB
Sodium ChlorideInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 0.223 mg in 1 mL
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Quantity: 0.04 mg in 1 mL
Code: 3980JIH2SW
Classification: IACT

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Legend - FDA Drug Approval Details