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Details for New Drug Application (NDA): 017351
The generic ingredient in CORTIFOAM is hydrocortisone acetate. There are sixty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 017351
Tradename: | CORTIFOAM |
Applicant: | Mylan Speciality Lp |
Ingredient: | hydrocortisone acetate |
Patents: | 0 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) |
Formulation / Manufacturing: | see details |
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 | Meda Pharmaceuticals | 0037-6830 | N | 0037-6830-15 |
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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