Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090313
Company: ECI PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT POWDER;ORAL, RECTAL Prescription AA 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
12/21/2011 ORIG-1 Approval

Label is not available on this site.

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL; 453.6GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT POWDER;ORAL, RECTAL Prescription No AA 090313 ECI PHARMS LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT POWDER;ORAL, RECTAL Prescription No AA 202333 EPIC PHARMA LLC

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