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Details for New Drug Application (NDA): 018514

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NDA 018514 describes LOCOID, which is a drug marketed by Yamanouchi and Precision Dermat and is included in eight NDAs. It is available from six suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LOCOID profile page.

The generic ingredient in LOCOID is hydrocortisone butyrate. There are fifty-three 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 NDA: 018514

Pharmacology for NDA: 018514

Suppliers and Packaging for NDA: 018514

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone butyrate
CREAM;TOPICAL 018514 NDA Onset Dermatologics, LLC 16781-382 16781-382-15 1 TUBE in 1 CARTON (16781-382-15) > 15 g in 1 TUBE
hydrocortisone butyrate
CREAM;TOPICAL 018514 NDA Onset Dermatologics, LLC 16781-382 16781-382-45 1 TUBE in 1 CARTON (16781-382-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Mar 31, 1982TE:AB1RLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.