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FDA Approval

Nitrous Oxide

CompanyRoberts Oxygen Company, Inc. (DUNS: 042646877)

Effective Date

November 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nitrous oxide(990 mL in 1 L)

Manufacturing Establishments (1)

Roberts Oxygen Company, Inc.

Labeler

Roberts Oxygen Company, Inc.

DUNS Number

791818008

Products (1)

Nitrous Oxide

NDC Product Code

46123-006

Application Number

NDA206009

Marketing Category

NDA (C73594)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

November 16, 2023

Ingredients

Nitrous oxideActive

Code: K50XQU1029Class: ACTIBQuantity: 990 mL in 1 L

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