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Ultane

ULTANE (sevoflurane) volatile liquid for inhalation novaplus

Approved
Approval ID

c9aa6489-5a36-44ed-9512-b996833d82f7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 18, 2022

Manufacturers
FDA

AbbVie Inc.

DUNS: 078458370

Products 1

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

Sevoflurane

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0074-4456
Application NumberNDA020478
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sevoflurane
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 8, 2022
FDA Product Classification

INGREDIENTS (1)

SEVOFLURANEActive
Quantity: 250 mL in 250 mL
Code: 38LVP0K73A
Classification: ACTIB

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Ultane - FDA Drug Approval Details