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Last Updated: April 13, 2024

Details for New Drug Application (NDA): 017351

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NDA 017351 describes CORTIFOAM, which is a drug marketed by Mylan Speciality Lp 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 are sixty-seven 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
Applicant:Mylan Speciality Lp
Ingredient:hydrocortisone acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 017351
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 Inc. 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:RXDosage:AEROSOL, METERED;RECTALStrength10%
Approval Date:Feb 10, 1982TE:RLD:Yes

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