Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040905
Company: KVK TECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KALEXATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription AA No Yes
KALEXATE SODIUM POLYSTYRENE SULFONATE 15GM/BOT POWDER;ORAL, RECTAL Prescription 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
03/30/2009 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
02/21/2020 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/08/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

KALEXATE

POWDER;ORAL, RECTAL; 454GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KALEXATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription No AA 040905 KVK TECH
KIONEX SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription No AA 040029 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription No AA 205727 BELCHER
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription No AA 089910 CMP PHARMA INC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription No AA 206815 NOVELGENIX THERAPS
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER;ORAL, RECTAL Prescription No AA 204071 NUVO PHARMS INC

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