Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075710
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| 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 40MG 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 |
|---|---|---|---|---|---|---|---|
| 02/06/2008 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/075710Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/31/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/22/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2013 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/01/2011 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Proposal |
Label is not available on this site. |
||
| 04/22/2010 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/20/2009 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |