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FDA Approval

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

FDA Approval Summary

Company
Medi-Physics Inc.
DUNS: 095263729
Effective Date
January 10, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments1

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

Medi-Physics Inc.

Medi-Physics Inc.

095263729

Products1

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

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Product Details

NDC Product Code
17156-235
Application Number
NDA022290
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 30, 2022
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956Class: IACTQuantity: 23 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 2.8 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.3 mg in 1 mL
Code: P2TH1XYZ84Class: ACTIBQuantity: 2 mCi in 1 mL
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