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Details for New Drug Application (NDA): 202354

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NDA 202354 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: 202354

Hikma Farmaceutica
Formulation / Manufacturing:see details

Pharmacology for NDA: 202354

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 202354

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 202354 ANDA West-Ward Pharmaceuticals Corp 0143-9506 0143-9506-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9506-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0143-9506-01)
INJECTABLE;INJECTION 202354 ANDA West-Ward Pharmaceuticals Corp 0143-9507 0143-9507-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9507-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0143-9507-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Feb 25, 2016TE:APRLD:No

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