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Arformoterol Tartrate Inhalation Solution

Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL These highlights do not include all the information needed to use ARFORMOTEROL TARTRATE INHALATION SOLUTION safely and effectively. See full prescribing information for ARFORMOTEROL TARTRATE INHALATION SOLUTION ARFORMOTEROL TARTRATE INHALATION SOLUTION Initial U.S. Approval: 2006

Approved
Approval ID

ef524b4c-68d7-c464-e053-2a95a90a7f96

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers
FDA

Ritedose Pharmaceuticals, LLC

DUNS: 968062294

Products 1

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

Arformoterol Tartrate Inhalation Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76204-026
Application NumberANDA214736
Product Classification
M
Marketing Category
C73584
G
Generic Name
Arformoterol Tartrate Inhalation Solution
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (1)

ARFORMOTEROL TARTRATEActive
Quantity: 15 ug in 2 mL
Code: 5P8VJ2I235
Classification: ACTIM

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Arformoterol Tartrate Inhalation Solution - FDA Drug Approval Details