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FDA Drug Approval, N17657, CEPHULAC
FDA Drug Approval, N17657, CEPHULAC
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NDA: 17657
Company: SANOFI AVENTIS US
Drug Name: CEPHULAC
Active Ingredients: LACTULOSE
Strength: 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SOLUTION;ORAL, RECTAL
Action Date: 01/00/1900
Marketing Status: Discontinued
Submission Classification:
Company: SANOFI AVENTIS US
Drug Name: CEPHULAC
Active Ingredients: LACTULOSE
Strength: 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SOLUTION;ORAL, RECTAL
Action Date: 01/00/1900
Marketing Status: Discontinued
Submission Classification:
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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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