Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071320
Company: DYNAPHARM
Company: DYNAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLOVAGE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 04/20/1988 | 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 |
|---|---|---|---|---|---|
| 08/29/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |