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Generated: November 12, 2018

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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 two suppliers. Additional details are available on the CORTIFOAM profile page.

The generic ingredient in CORTIFOAM is hydrocortisone acetate. There are sixty-five 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
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 0037-6830 0037-6830-15 1 CANISTER in 1 CARTON (0037-6830-15) > 15 g in 1 CANISTER
CORTIFOAM hydrocortisone acetate AEROSOL, METERED;RECTAL 017351 NDA Alaven Pharmaceutical LLC 68220-140 68220-140-15 1 CONTAINER in 1 CARTON (68220-140-15) > 15 g in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;RECTALStrength10%
Approval Date:Feb 10, 1982TE:RLD:Yes

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