Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078565
Company: WOCKHARDT USA
Company: WOCKHARDT USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 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 |
|---|---|---|---|---|---|---|---|
| 06/30/2008 | 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 |
|---|---|---|---|---|---|
| 02/25/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |