Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219282
Company: INTRA SANA LABS
Company: INTRA SANA LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 2MG BASE/10ML | SOLUTION;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 03/17/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |