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Details for New Drug Application (NDA): 018227

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NDA 018227 describes AMIDATE, which is a drug marketed by Hospira and is included in one NDA. It is available from three suppliers. Additional details are available on the AMIDATE profile page.

The generic ingredient in AMIDATE is etomidate. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the etomidate profile page.

Summary for NDA: 018227

Formulation / Manufacturing:see details

Pharmacology for NDA: 018227

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 018227

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 018227 NDA Hospira, Inc. 0409-6695 0409-6695-10 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-6695-09)
INJECTABLE;INJECTION 018227 NDA Hospira, Inc. 0409-6695 0409-6695-20 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-20) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-6695-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Sep 7, 1982TE:APRLD:Yes

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