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Generated: January 16, 2019

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Details for New Drug Application (NDA): 013790

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NDA 013790 describes CORDRAN, which is a drug marketed by Aqua Pharms, Aqua Pharms 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 013790
Applicant:Aqua Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 013790
Suppliers and Packaging for NDA: 013790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORDRAN flurandrenolide LOTION;TOPICAL 013790 NDA Aqua Pharmaceuticals 16110-052 16110-052-12 120 mL in 1 BOTTLE, PLASTIC (16110-052-12)
CORDRAN flurandrenolide LOTION;TOPICAL 013790 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-5298 51672-5298-8 1 BOTTLE, PLASTIC in 1 CARTON (51672-5298-8) > 120 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

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

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