MedPath
FDA Approval

ANUCORT-HC

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

FDA Approval Summary

Company
Effective Date
November 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Cosette Pharmaceuticals, Inc.

116918230

Manufacturing Establishments1

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

Cosette Pharmaceuticals NC Laboratories, LLC

Cosette Pharmaceuticals, Inc.

Cosette Pharmaceuticals, Inc.

079419931

Products1

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

ANUCORT-HC

Product Details

NDC Product Code
0713-0503
Route of Administration
RECTAL
Effective Date
November 22, 2023
Code: 3X7931PO74Class: ACTIBQuantity: 25 mg in 1 1
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VPClass: IACT
© Copyright 2025. All Rights Reserved by MedPath