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Harvard Business School
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Express Scripts
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Dow
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076153

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NDA 076153 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 076153
Tradename:PAMIDRONATE DISODIUM
Applicant:Teva Pharms Usa
Ingredient:pamidronate disodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076153
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 076153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 076153 ANDA Teva Parenteral Medicines, Inc. 0703-4075 N 0703-4075-51
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 076153 ANDA Teva Parenteral Medicines, Inc. 0703-4085 N 0703-4085-51

Profile for product number 001

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

Profile for product number 002

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

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Baxter
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