Visitor Monitoring Drug History: HALFLYTELY
 
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Label and Approval History

Drug Name: HALFLYTELY
FDA Application No: (NDA) 021551
Active Ingredient(s): BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Company: BRAINTREE
 
Label History
 
View the label approved on September 26, 2007 for HALFLYTELY, (NDA) 021551


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/24/2007 006New Dosage Regimen Letter
Label 
5/18/2006 005Labeling Revision Letter
Label 
2/23/2005 003Control Supplement Letter 
5/10/2004 000Approval Letter
Label
Review 
 
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