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FDA Approval

Adasuve

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 9, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Loxapine(10 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals, Inc.

018849948

Products1

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

Adasuve

Product Details

NDC Product Code
51097-001
Application Number
NDA022549
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 9, 2024
LoxapineActive
Code: LER583670JClass: ACTIBQuantity: 10 mg in 1 1
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