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Details for New Drug Application (NDA): 086195

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

The generic ingredient in PROCTOFOAM HC is hydrocortisone acetate; pramoxine hydrochloride. There are fifty-six 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 NDA: 086195

Tradename:
PROCTOFOAM HC
Applicant:
Meda Pharms
Ingredient:
hydrocortisone acetate; pramoxine hydrochloride
Patents:0
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 Rebel Distributors Corp 21695-982 21695-982-10 1 CONTAINER in 1 CARTON (21695-982-10) > 10 g in 1 CONTAINER
PROCTOFOAM HC
hydrocortisone acetate; pramoxine hydrochloride
AEROSOL, METERED;TOPICAL 086195 ANDA Alaven Pharmaceutical LLC 68220-142 68220-142-10 1 CONTAINER in 1 CARTON (68220-142-10) > 10 g in 1 CONTAINER

Summary 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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