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Queensland Health
Cantor Fitzgerald
US Army

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086195

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NDA 086195 describes PROCTOFOAM HC, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from three suppliers. Additional details are available on the PROCTOFOAM HC profile page.

The generic ingredient in PROCTOFOAM HC is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 086195
Applicant:Mylan Speciality Lp
Ingredient:hydrocortisone acetate; pramoxine hydrochloride
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 086195
Suppliers and Packaging for NDA: 086195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCTOFOAM HC hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086195 ANDA Meda Pharmaceuticals 0037-6822 N 0037-6822-10
PROCTOFOAM HC hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086195 ANDA Rebel Distributors Corp 21695-982 E 21695-982-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;TOPICALStrength1%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:BXRLD:No

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Harvard Business School
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