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Generated: November 17, 2018

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Details for New Drug Application (NDA): 018652

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NDA 018652 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 018652
Tradename:LOCOID
Applicant:Precision Dermat
Ingredient:hydrocortisone butyrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018652
Suppliers and Packaging for NDA: 018652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOCOID hydrocortisone butyrate OINTMENT;TOPICAL 018652 NDA Oceanside Pharmaceuticals 68682-271 68682-271-15 1 TUBE in 1 CARTON (68682-271-15) > 15 g in 1 TUBE
LOCOID hydrocortisone butyrate OINTMENT;TOPICAL 018652 NDA Oceanside Pharmaceuticals 68682-271 68682-271-45 1 TUBE in 1 CARTON (68682-271-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Oct 29, 1982TE:ABRLD:Yes

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