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FDA Approval Letter and Labeling – ANDA 217721 Ephedrine Sulfate
FDA Approval Letter and Labeling – ANDA 217721 Ephedrine Sulfate
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Original Request: Good afternoon, I am requesting a copy of the FDA Approval Letter and the approved labeling for recently approved (10/11/2024) Abbreviated New Drug Application below: ANDA: 217721 Company: Hikma Ephedrine Sulfate 25MG/5ML (5MG/ML) SOLUTION;INTRAVENOUS Although listed on Drugs@FDA, the letter and labeling are not available there, nor is the labeling available on DailyMed.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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