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
0713-0503Route of Administration
RECTALEffective Date
November 22, 2023Hydrocortisone acetateActive
Code: 3X7931PO74Class: ACTIBQuantity: 25 mg in 1 1
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VPClass: IACT