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Generated: November 14, 2018

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Details for New Drug Application (NDA): 022076

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NDA 022076 describes LOCOID, which is a drug marketed by Precision Dermat and Yamanouchi 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-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 022076
Tradename:LOCOID
Applicant:Precision Dermat
Ingredient:hydrocortisone butyrate
Patents:2
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 Onset Dermatologics, 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 Onset Dermatologics, LLC 16781-392 16781-392-04 1 BOTTLE in 1 CARTON (16781-392-04) > 118 mL in 1 BOTTLE

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

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