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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076068

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NDA 076068 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Gland Pharma Ltd, Mylan Institutional, and West-ward Pharms Int, and is included in three NDAs. It is available from five 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:1
Applicant:1
Ingredient:1
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 West-Ward Pharmaceuticals Corp 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 West-Ward Pharmaceuticals Corp 0143-9248 0143-9248-01 1 VIAL in 1 BOX (0143-9248-01) > 50 mL in 1 VIAL

Summary for product number 001

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

Summary 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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Harvard Business School
Cerilliant

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