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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Federal Trade Commission
QuintilesIMS
Accenture
Cantor Fitzgerald
Citi
Cerilliant
Healthtrust
AstraZeneca

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085979

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NDA 085979 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 085979
Tradename:PRAMOSONE
Applicant:Sebela Ireland Ltd
Ingredient:hydrocortisone acetate; pramoxine hydrochloride
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085979
Suppliers and Packaging for NDA: 085979
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085979 ANDA Sebela Pharmaceuticals Inc. 54766-726 54766-726-04 118 mL in 1 BOTTLE, PLASTIC (54766-726-04)
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085979 ANDA Sebela Pharmaceuticals Inc. 54766-726 54766-726-06 59 mL in 1 BOTTLE, PLASTIC (54766-726-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength2.5%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Deloitte
Colorcon
Harvard Business School
Baxter
Cipla
Moodys
Accenture
Cerilliant
Fish and Richardson

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