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FDA Approval

Cortisone Acetate

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

FDA Approval Summary

Company
Chartwell RX, LLC
DUNS: 079394054
Effective Date
January 19, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cortisone acetate(25 mg in 1 1)

Products1

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

Cortisone Acetate

Product Details

NDC Product Code
62135-173
Application Number
ANDA080694
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 19, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: 883WKN7W8XClass: ACTIBQuantity: 25 mg in 1 1
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