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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 072123


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NDA 072123 describes DROPERIDOL, which is a drug marketed by Abraxis Pharm, Am Regent, Astrazeneca, Hikma, Hospira, Igi Labs Inc, Luitpold, Smith And Nephew, Solopak, and Watson Labs, and is included in eighteen NDAs. It is available from two suppliers. Additional details are available on the DROPERIDOL profile page.

The generic ingredient in DROPERIDOL is droperidol. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the droperidol profile page.
Summary for 072123
Tradename:DROPERIDOL
Applicant:Am Regent
Ingredient:droperidol
Patents:0
Pharmacology for NDA: 072123
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 072123
Suppliers and Packaging for NDA: 072123
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROPERIDOL droperidol INJECTABLE;INJECTION 072123 ANDA American Regent, Inc. 0517-9702 0517-9702-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9702-25) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5MG/ML
Approval Date:Oct 24, 1988TE:RLD:No

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