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Generated: September 19, 2018

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Details for New Drug Application (NDA): 012806

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NDA 012806 describes CORDRAN, which is a drug marketed by Aqua Pharms, Allergan Sales Llc, and Lilly, and is included in five NDAs. It is available from three suppliers. Additional details are available on the CORDRAN profile page.

The generic ingredient in CORDRAN is flurandrenolide; neomycin sulfate. There are four drug master file entries for this compound. Additional details are available on the flurandrenolide; neomycin sulfate profile page.
Summary for 012806
Tradename:CORDRAN
Applicant:Aqua Pharms
Ingredient:flurandrenolide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 012806
Suppliers and Packaging for NDA: 012806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORDRAN SP flurandrenolide CREAM;TOPICAL 012806 NDA Aqua Pharmaceuticals 16110-026 16110-026-60 1 TUBE in 1 CARTON (16110-026-60) > 60 g in 1 TUBE
CORDRAN flurandrenolide OINTMENT;TOPICAL 012806 NDA Aqua Pharmaceuticals 16110-026 16110-026-60 1 TUBE in 1 CARTON (16110-026-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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