Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090197
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL 2MG; 5MG SOLUTION; ORAL AND TABLET; DELAYED RELEASE None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/27/2010 ORIG-1 Tentative Approval

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