Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077842
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG 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 |
|---|---|---|---|---|---|---|---|
| 12/31/2007 | 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 |
|---|---|---|---|---|---|
| 08/12/2022 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/18/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2010 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/04/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |