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FDA Drug Approval, N020073, ROMAZICON
FDA Drug Approval, N020073, ROMAZICON
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NDA: 020073
Company: HOFFMANN LA ROCHE
Drug Name: ROMAZICON
Active Ingredients: FLUMAZENIL
Strength: 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/20/1991
Marketing Status: Discontinued
Submission Classification: Type 1 - New Molecular Entity
Company: HOFFMANN LA ROCHE
Drug Name: ROMAZICON
Active Ingredients: FLUMAZENIL
Strength: 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/20/1991
Marketing Status: Discontinued
Submission Classification: Type 1 - New Molecular Entity
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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