Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040028
Company: ANI PHARMS
Company: ANI PHARMS
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 |
---|---|---|---|---|---|
05/03/2024 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
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 | ANI PHARMS |
SPS | SODIUM POLYSTYRENE SULFONATE | 15GM/60ML | SUSPENSION;ORAL, RECTAL | Prescription | Yes | AA | 087859 | CMP PHARMA INC |