Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090197
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL | POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL | 2MG; 5MG | SOLUTION; ORAL AND TABLET; DELAYED RELEASE | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/2010 | ORIG-1 | Tentative Approval |
Label is not available on this site. |