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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022076

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NDA 022076 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 022076
Ingredient:hydrocortisone butyrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 022076
Suppliers and Packaging for NDA: 022076
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOCOID hydrocortisone butyrate LOTION;TOPICAL 022076 NDA Bausch Health US LLC 16781-392 16781-392-02 1 BOTTLE in 1 CARTON (16781-392-02) > 59 mL in 1 BOTTLE
LOCOID hydrocortisone butyrate LOTION;TOPICAL 022076 NDA Bausch Health US LLC 16781-392 16781-392-04 1 BOTTLE in 1 CARTON (16781-392-04) > 118 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022076
Tradename Dosage Ingredient NDA Submissiondate
LOCOID LOTION;TOPICAL hydrocortisone butyrate 022076 2016-08-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.1%
Approval Date:May 18, 2007TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 19, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jan 23, 2025Product Flag?YSubstance Flag?Delist Request?

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