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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090019
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Discontinued 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
05/27/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/05/2009 SUPPL-1 Labeling

Label is not available on this site.

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