Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090557
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
| 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 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 |
|---|---|---|---|---|---|---|---|
| 02/18/2010 | 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 |
|---|---|---|---|---|---|
| 10/14/2022 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2012 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/30/2012 | SUPPL-1 | Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |