Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078808
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2008 | 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 |
|---|---|---|---|---|---|
| 06/13/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2014 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/17/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |