Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075871
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/2009 | 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 |
|---|---|---|---|---|---|
| 02/25/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |