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Serving leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Daiichi Sankyo
Johnson and Johnson

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085368

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NDA 085368 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 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 085368

Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 085368

Suppliers and Packaging for NDA: 085368

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride CREAM;TOPICAL 085368 ANDA Sebela Pharmaceuticals Inc. 54766-716 54766-716-03 57 g in 1 TUBE (54766-716-03)
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride CREAM;TOPICAL 085368 ANDA Sebela Pharmaceuticals Inc. 54766-716 54766-716-04 28.4 g in 1 TUBE (54766-716-04)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School

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