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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 019116

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NDA 019116 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 019116
Ingredient:hydrocortisone butyrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019116
Suppliers and Packaging for NDA: 019116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019116 NDA Bausch Health US, LLC 16781-391 16781-391-60 1 BOTTLE in 1 CARTON (16781-391-60) > 60 mL in 1 BOTTLE
LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019116 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-273 68682-273-61 1 BOTTLE in 1 CARTON (68682-273-61) > 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.1%
Approval Date:Feb 25, 1987TE:ATRLD:Yes

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
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