Application Information

This drug has been submitted to the FDA under the reference 020073/001.

Names and composition

"ROMAZICON" is the commercial name of a drug composed of FLUMAZENIL.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020073/001 ROMAZICON FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020073/002 ROMAZICON FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020073/001 ROMAZICON FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020073/002 ROMAZICON FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
076256/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
076256/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
076589/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
076589/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
076755/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
076755/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
076787/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
076787/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
076955/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
076955/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
077071/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
077071/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
078527/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
078527/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
078595/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
078595/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)
090584/001 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 0.5MG per 5ML (0.1MG per ML)
090584/002 FLUMAZENIL FLUMAZENIL INJECTABLE/INJECTION 1MG per 10ML (0.1MG per ML)

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