Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202671
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 09/02/2014 | 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 |
|---|---|---|---|---|---|
| 02/03/2026 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/06/2025 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/06/2018 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/06/2018 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |