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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice

Generated: May 20, 2018

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
Applicant:Cintex Svcs
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 N 24470-919-12
FLURANDRENOLIDE flurandrenolide CREAM;TOPICAL 205342 ANDA Cintex Services, LLC 24470-919 N 24470-919-60

Profile for product number 001

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

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