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FDA Approval

Hydrocortisone Acetate

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

FDA Approval Summary

Company
Vitruvias Therapeutics
DUNS: 079200795
Effective Date
June 4, 2021
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.

Graxcell Pharmaceutical, LLC.

Vitruvias Therapeutics

080805631

Products1

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

Hydrocortisone Acetate

Product Details

NDC Product Code
69680-144
Route of Administration
RECTAL
Effective Date
June 4, 2021
Code: 3X7931PO74Class: ACTIBQuantity: 25 mg in 1 1
HYDROGENATED COCO-GLYCERIDESInactive
Code: XDD37N2GPRClass: IACT
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