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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 018514


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NDA 018514 describes LOCOID, which is a drug marketed by Bausch, Yamanouchi, and Precision Dermat, and is included in eight NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LOCOID profile page.

The generic ingredient in LOCOID is hydrocortisone butyrate. There are sixty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 018514
Tradename:LOCOID
Applicant:Bausch
Ingredient:hydrocortisone butyrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018514
Suppliers and Packaging for NDA: 018514
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOCOID hydrocortisone butyrate CREAM;TOPICAL 018514 NDA Bausch Health US, LLC 16781-382 16781-382-15 1 TUBE in 1 CARTON (16781-382-15) > 15 g in 1 TUBE
LOCOID hydrocortisone butyrate CREAM;TOPICAL 018514 NDA Bausch Health US, LLC 16781-382 16781-382-45 1 TUBE in 1 CARTON (16781-382-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Mar 31, 1982TE:AB1RLD:Yes

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