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Generated: January 23, 2019

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Details for New Drug Application (NDA): 016455

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NDA 016455 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 016455
Applicant:Aqua Pharms Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 016455
Suppliers and Packaging for NDA: 016455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORDRAN flurandrenolide TAPE;TOPICAL 016455 NDA Allergan, Inc. 0023-5870 0023-5870-24 450 cm2 in 1 CARTON (0023-5870-24)
CORDRAN flurandrenolide TAPE;TOPICAL 016455 NDA Allergan, Inc. 0023-5870 0023-5870-80 1500 cm2 in 1 CARTON (0023-5870-80)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TAPE;TOPICALStrength0.004MG/SQ CM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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