Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200477
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Discontinued | None | No | No |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 75MG | TABLET;ORAL | Discontinued | None | No | No |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/30/2015 | ORIG-2 | Approval | Not Applicable |
Label is not available on this site. |
|||
| 06/10/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2015 | SUPPL-2 | Labeling-Medication Guide |
Label is not available on this site. |