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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Medtronic
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QuintilesIMS
Baxter
US Army
Moodys

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075841

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NDA 075841 describes PAMIDRONATE DISODIUM, which is a drug marketed by Aesgen, Areva Pharms, Fresenius Kabi Usa, Hospira, Luitpold, Mn Pharms, Mylan Labs Ltd, Pliva Lachema, Sagent Pharms, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the PAMIDRONATE DISODIUM profile page.

The generic ingredient in PAMIDRONATE DISODIUM is pamidronate disodium. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.
Summary for 075841
Tradename:PAMIDRONATE DISODIUM
Applicant:Hospira
Ingredient:pamidronate disodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075841
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 075841
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 075841 ANDA Hospira, Inc. 61703-324 N 61703-324-18
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 075841 ANDA Hospira, Inc. 61703-325 N 61703-325-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/10ML (3MG/ML)
Approval Date:Jun 27, 2002TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength60MG/10ML (6MG/ML)
Approval Date:Jun 27, 2002TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength90MG/10ML (9MG/ML)
Approval Date:Jun 27, 2002TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
US Department of Justice
Boehringer Ingelheim
Queensland Health
Cerilliant
Cipla
US Army
Harvard Business School

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