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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
US Army

Generated: December 11, 2017

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 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

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 54766-729-04 118 mL in 1 BOTTLE (54766-729-04)
PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980 ANDA Sebela Pharmaceuticals Inc. 54766-729 54766-729-03 236 mL in 1 BOTTLE (54766-729-03)

Summary 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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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School

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