Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090019
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | FOR SOLUTION;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/2009 | 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 |
|---|---|---|---|---|---|
| 06/23/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/05/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |