Details for New Drug Application (NDA): 050731
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NDA 050731 describes DAUNORUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the DAUNORUBICIN HYDROCHLORIDE profile page.
The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
Summary for 050731
| Tradename: | DAUNORUBICIN HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | daunorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 050731
| Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 050731
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 050731 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9550 | 0143-9550-01 | 1 VIAL in 1 CARTON (0143-9550-01) / 10 mL in 1 VIAL |
| DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 050731 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9551 | 0143-9551-10 | 10 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Jan 30, 1998 | TE: | AP | RLD: | Yes | ||||
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