Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076184
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG 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/2008/076184s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2012 | SUPPL-5 | Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2009 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/04/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/04/2008 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |