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Adasuve

These highlights do not include all the information needed to use ADASUVE safely and effectively. See full prescribing information for ADASUVE. ADASUVE (loxapine) inhalation powder, for oral inhalation use Initial U.S. Approval: 1975

Approved
Approval ID

50e11732-7387-452d-b3e6-db3a431d5c4a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

Alexza Pharmaceuticals, Inc.

DUNS: 018849948

Products 1

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

loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51097-001
Application NumberNDA022549
Product Classification
M
Marketing Category
C73594
G
Generic Name
loxapine
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (1)

LOXAPINEActive
Quantity: 10 mg in 1 1
Code: LER583670J
Classification: ACTIB

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Adasuve - FDA Drug Approval Details