Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202333
Company: EPIC PHARMA LLC
Company: EPIC PHARMA 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 |
---|---|---|---|---|---|---|---|
03/19/2014 | 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 |
---|---|---|---|---|---|
02/25/2020 | SUPPL-1 | Labeling-Package Insert |
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 | 202333 | EPIC PHARMA LLC |
SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE | 453.6GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 090313 | UPSHER SMITH LABS |