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Details for New Drug Application (NDA): 017351
NDA 017351 describes CORTIFOAM, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the CORTIFOAM profile page.
The generic ingredient in CORTIFOAM is hydrocortisone acetate. There are sixty-four drug master file entries 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 are sixty-four drug master file entries 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: | 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 |
| CORTIFOAM | hydrocortisone acetate | AEROSOL, METERED;RECTAL | 017351 | NDA | Alaven Pharmaceutical LLC | 68220-140 | E | 68220-140-15 |
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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