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Generated: May 25, 2017

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Details for New Drug Application (NDA): 071981

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NDA 071981 describes DROPERIDOL, which is a drug marketed by Astrazeneca, Igi Labs Inc, Watson Labs, Luitpold, Hospira, Smith And Nephew, Solopak, and Abraxis Pharm, and is included in seventeen NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the droperidol profile page.

Summary for NDA: 071981

Formulation / Manufacturing:see details

Pharmacology for NDA: 071981

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 071981

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 071981 ANDA Hospira, Inc. 0409-1187 0409-1187-01 10 AMPULE in 1 CARTON (0409-1187-01) > 2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5MG/ML
Approval Date:Feb 29, 1988TE:APRLD:No

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