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Chinese Patent Office
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Generated: June 23, 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 Ferndale Labs and Sebela Ireland Ltd 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 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 NDA: 085368

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 500+ biopharmaceutical companies globally:

Deloitte
Covington
McKesson
Accenture
Dow
UBS
US Army
Teva
Queensland Health
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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