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Generated: November 21, 2018

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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-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 020769
Tradename:LOCOID LIPOCREAM
Applicant:Precision Dermat
Ingredient:hydrocortisone butyrate
Patents:0
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 16781-384-45 1 TUBE in 1 CARTON (16781-384-45) > 45 g in 1 TUBE
LOCOID LIPOCREAM hydrocortisone butyrate CREAM;TOPICAL 020769 NDA Onset Dermatologics LLC 16781-384 16781-384-60 1 TUBE in 1 CARTON (16781-384-60) > 60 g in 1 TUBE

Profile for product number 001

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

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