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Details for New Drug Application (NDA): 065035

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NDA 065035 describes DAUNORUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Teva Parenteral, West-ward Pharms Int, and Teva Pharms Usa, and is included in five NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

Summary for NDA: 065035

Teva Pharms Usa
daunorubicin hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 065035

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065035

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
daunorubicin hydrochloride
INJECTABLE;INJECTION 065035 ANDA Teva Parenteral Medicines, Inc. 0703-5233 0703-5233-13 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-5233-13) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-5233-11)
daunorubicin hydrochloride
INJECTABLE;INJECTION 065035 ANDA Teva Parenteral Medicines, Inc. 0703-5233 0703-5233-93 10 VIAL, SINGLE-DOSE in 1 TRAY (0703-5233-93) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-5233-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jan 24, 2000TE:APRLD:No

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