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Last Updated: December 27, 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 Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 072123

Adjuvants, Anesthesia
Antiemetics
Antipsychotic Agents
Dopamine D2 Receptor Antagonists

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.5MG/ML
Approval Date:	Oct 24, 1988	TE:		RLD:	No

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