Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065036
Company: MEITHEAL
Company: MEITHEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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/2002/65036ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/2023 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2022 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2011 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
IDARUBICIN HYDROCHLORIDE
SOLUTION;INTRAVENOUS; 5MG/5ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IDAMYCIN PFS | IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 050734 | PFIZER |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065275 | HIKMA |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065288 | HIKMA |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065036 | MEITHEAL |
SOLUTION;INTRAVENOUS; 10MG/10ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065275 | HIKMA |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065288 | HIKMA |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065036 | MEITHEAL |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 050734 | PFIZER |
SOLUTION;INTRAVENOUS; 20MG/20ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065275 | HIKMA |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065288 | HIKMA |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 065036 | MEITHEAL |
| IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 050734 | PFIZER |