Details for New Drug Application (NDA): 065036
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NDA 065036 describes IDARUBICIN HYDROCHLORIDE, which is a drug marketed by Teva Parenteral, Fresenius Kabi Usa, Hikma, Meitheal, Pfizer, Rising, and Sandoz, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the IDARUBICIN HYDROCHLORIDE profile page.
The generic ingredient in IDARUBICIN HYDROCHLORIDE is idarubicin hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.
The generic ingredient in IDARUBICIN HYDROCHLORIDE is idarubicin hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.
Summary for 065036
| Tradename: | IDARUBICIN HYDROCHLORIDE |
| Applicant: | Meitheal |
| Ingredient: | idarubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 065036
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 065036
Suppliers and Packaging for NDA: 065036
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | SOLUTION;INTRAVENOUS | 065036 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-184 | 71288-184-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-184-05) / 5 mL in 1 VIAL, SINGLE-DOSE |
| IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | SOLUTION;INTRAVENOUS | 065036 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-185 | 71288-185-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-185-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/5ML (1MG/ML) | ||||
| Approval Date: | May 1, 2002 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | May 1, 2002 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/20ML (1MG/ML) | ||||
| Approval Date: | May 1, 2002 | TE: | AP | RLD: | No | ||||
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