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Generated: November 17, 2018

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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 two 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. Eleven suppliers are listed for this compound. Additional details are available on the etomidate profile page.
Summary for 018227
Tradename:AMIDATE
Applicant:Hospira
Ingredient:etomidate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018227
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 018227
Suppliers and Packaging for NDA: 018227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIDATE etomidate INJECTABLE;INJECTION 018227 NDA Hospira, Inc. 0409-6695 0409-6695-01 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-01) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-6695-11)
AMIDATE etomidate INJECTABLE;INJECTION 018227 NDA Hospira, Inc. 0409-6695 0409-6695-02 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-02) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-6695-12)

Profile for product number 001

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

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