Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065037
Company: TEVA PARENTERAL
Company: TEVA PARENTERAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/VIAL | POWDER;INTRAVENOUS | Discontinued | None | No | No |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/VIAL | POWDER;INTRAVENOUS | Discontinued | None | No | No |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 5MG/VIAL | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 05/01/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65037ltr.pdf |