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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 three suppliers. Additional details are available on the LOCOID LIPOCREAM profile page.

The generic ingredient in LOCOID LIPOCREAM is hydrocortisone butyrate. There are fifty-seven 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 NDA: 020769

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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
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
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020769

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Precision Dermat
hydrocortisone butyrate
CREAM;TOPICAL020769-001Sep 8, 19975,635,497► Subscribe
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