Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079003
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG 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 |
|---|---|---|---|---|---|---|---|
| 03/20/2012 | ORIG-1 | Approval |
Review (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/079003Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/079003Orig1s000OtherActionLtrs.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2026 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |