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Serving leading biopharmaceutical companies globally:

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Chinese Patent Office
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200752

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NDA 200752 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 200752

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 200752

Suppliers and Packaging for NDA: 200752

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752 ANDA Mylan Institutional LLC 67457-207 67457-207-25 1 KIT in 1 PACKAGE (67457-207-25) * 25 mL in 1 VIAL, SINGLE-DOSE (67457-204-25) * 25 mL in 1 VIAL (67457-205-25)
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752 ANDA Mylan Institutional LLC 67457-208 67457-208-50 1 KIT in 1 PACKAGE (67457-208-50) * 50 mL in 1 VIAL, SINGLE-DOSE (67457-209-50) * 50 mL in 1 VIAL (67457-205-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Oct 19, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Oct 19, 2011TE:APRLD:No


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