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Serving leading biopharmaceutical companies globally:

Chubb
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Cipla
Dow
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Farmers Insurance
US Department of Justice
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205342

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NDA 205342 describes FLURANDRENOLIDE, which is a drug marketed by Cintex Svcs, Alpharma Us Pharms, Perrigo Uk Finco, and Teligent Pharma Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the FLURANDRENOLIDE profile page.

The generic ingredient in FLURANDRENOLIDE is flurandrenolide. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the flurandrenolide profile page.

Summary for 205342

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 205342

Suppliers and Packaging for NDA: 205342

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLURANDRENOLIDE flurandrenolide CREAM;TOPICAL 205342 ANDA Cintex Services, LLC 24470-919 24470-919-60 60 g in 1 TUBE (24470-919-60)
FLURANDRENOLIDE flurandrenolide CREAM;TOPICAL 205342 ANDA Cintex Services, LLC 24470-919 24470-919-12 2 TUBE in 1 CARTON (24470-919-12) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Apr 13, 2016TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Merck
Queensland Health
Baxter
Boehringer Ingelheim
Fish and Richardson
Accenture
Cantor Fitzgerald
Mallinckrodt
McKesson

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