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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 076068


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NDA 076068 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland, and Hikma, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the DEXRAZOXANE HYDROCHLORIDE profile page.

The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 076068
Tradename:DEXRAZOXANE HYDROCHLORIDE
Applicant:Hikma
Ingredient:dexrazoxane hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076068
Medical Subject Heading (MeSH) Categories for 076068
Suppliers and Packaging for NDA: 076068
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 076068 ANDA Hikma Pharmaceuticals USA Inc. 0143-9247 0143-9247-01 1 VIAL in 1 BOX (0143-9247-01) / 25 mL in 1 VIAL
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 076068 ANDA Hikma Pharmaceuticals USA Inc. 0143-9248 0143-9248-01 1 VIAL in 1 BOX (0143-9248-01) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Sep 28, 2004TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Sep 28, 2004TE:APRLD:No

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