Details for New Drug Application (NDA): 017351
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NDA 017351 describes CORTIFOAM, which is a drug marketed by Viatris and is included in one NDA. It is available from one supplier. Additional details are available on the CORTIFOAM profile page.
The generic ingredient in CORTIFOAM is hydrocortisone acetate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
The generic ingredient in CORTIFOAM is hydrocortisone acetate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 017351
| Tradename: | CORTIFOAM |
| Applicant: | Viatris |
| Ingredient: | hydrocortisone acetate |
| Patents: | 0 |
Pharmacology for NDA: 017351
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 017351
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CORTIFOAM | hydrocortisone acetate | AEROSOL, METERED;RECTAL | 017351 | NDA | Viatris Specialty LLC | 0037-6830 | 0037-6830-15 | 1 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;RECTAL | Strength | 10% | ||||
| Approval Date: | Feb 10, 1982 | TE: | RLD: | Yes | |||||
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