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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083213

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NDA 083213 describes PRAMOSONE, which is a drug marketed by Sebela Ireland Ltd and Ferndale Labs and is included in five NDAs. It is available from two suppliers. 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. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 083213
Tradename:PRAMOSONE
Applicant:Ferndale Labs
Ingredient:hydrocortisone acetate; pramoxine hydrochloride
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength0.5%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Cerilliant
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