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Details for New Drug Application (NDA): 202360

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NDA 202360 describes ETOMIDATE, which is a drug marketed by Emcure Pharms Ltd, Hikma Farmaceutica, Zydus Pharms Usa Inc, Luitpold, Mylan Labs Ltd, Eurohlth Intl Sarl, and Par Sterile Products, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the ETOMIDATE profile page.

The generic ingredient in ETOMIDATE 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 NDA: 202360

Tradename:
ETOMIDATE
Applicant:
Zydus Pharms Usa Inc
Ingredient:
etomidate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202360

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 202360

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETOMIDATE
etomidate
INJECTABLE;INJECTION 202360 ANDA Cadila Healthcare Limited 65841-818 65841-818-07 10 VIAL in 1 TRAY (65841-818-07) > 10 mL in 1 VIAL
ETOMIDATE
etomidate
INJECTABLE;INJECTION 202360 ANDA Cadila Healthcare Limited 65841-818 65841-818-08 10 VIAL in 1 TRAY (65841-818-08) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jul 18, 2014TE:APRLD:No


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