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Generated: August 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 three 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. Five suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.

Summary for NDA: 076068

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

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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Serving 500+ biopharmaceutical companies globally:

Baxter
Colorcon
Moodys
Cerilliant
Queensland Health
Accenture
Novartis
Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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