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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085980

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NDA 085980 describes PRAMOSONE, which is a drug marketed by Sebela Ireland Ltd and Ferndale Labs and is included in five NDAs. It is available from one supplier. Additional details are available on the PRAMOSONE profile page.

The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 085980
Tradename:PRAMOSONE
Applicant:Sebela Ireland Ltd
Ingredient:hydrocortisone acetate; pramoxine hydrochloride
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085980
Suppliers and Packaging for NDA: 085980
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980 ANDA Sebela Pharmaceuticals Inc. 54766-729 N 54766-729-06
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980 ANDA Sebela Pharmaceuticals Inc. 54766-729 N 54766-729-04

Profile for product number 001

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

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