Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040028
Company: PADDOCK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KIONEX SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;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
09/17/2007 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/040028Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

KIONEX

SUSPENSION;ORAL, RECTAL; 15GM/60ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KIONEX SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 040028 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 090590 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 089049 WEST-WARD PHARMS INT
SPS SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 087859 CMP PHARMA INC

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