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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 208197


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NDA 208197 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 208197
Tradename:DROPERIDOL
Applicant:Hikma
Ingredient:droperidol
Patents:0
Pharmacology for NDA: 208197
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 208197
Suppliers and Packaging for NDA: 208197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROPERIDOL droperidol INJECTABLE;INJECTION 208197 ANDA Hikma Pharmaceuticals USA Inc. 0143-9514 0143-9514-25 25 VIAL in 1 CARTON (0143-9514-25) / 2 mL in 1 VIAL (0143-9514-01)
DROPERIDOL droperidol INJECTABLE;INJECTION 208197 ANDA Hikma Pharmaceuticals USA Inc. 0143-9515 0143-9515-25 25 VIAL in 1 CARTON (0143-9515-25) / 1 mL in 1 VIAL (0143-9515-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2.5MG/ML
Approval Date:Dec 14, 2017TE:RLD:No

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