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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020769

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NDA 020769 describes LOCOID LIPOCREAM, which is a drug marketed by Precision Dermat and is included in one NDA. It is available from two suppliers. Additional details are available on the LOCOID LIPOCREAM profile page.

The generic ingredient in LOCOID LIPOCREAM 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 020769
Applicant:Precision Dermat
Ingredient:hydrocortisone butyrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020769
Suppliers and Packaging for NDA: 020769
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOCOID LIPOCREAM hydrocortisone butyrate CREAM;TOPICAL 020769 NDA Onset Dermatologics LLC 16781-384 16781-384-18 18 TUBE in 1 CARTON (16781-384-18) > 2 g in 1 TUBE
LOCOID LIPOCREAM hydrocortisone butyrate CREAM;TOPICAL 020769 NDA Onset Dermatologics LLC 16781-384 16781-384-45 1 TUBE in 1 CARTON (16781-384-45) > 45 g in 1 TUBE
Paragraph IV (Patent) Challenges for 020769
Tradename Dosage Ingredient NDA Submissiondate
LOCOID LIPOCREAM CREAM;TOPICAL hydrocortisone butyrate 020769 2010-06-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Sep 8, 1997TE:AB2RLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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