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Healthtrust
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076207

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NDA 076207 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 076207
Tradename:PAMIDRONATE DISODIUM
Applicant:Fresenius Kabi Usa
Ingredient:pamidronate disodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076207
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 076207
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 076207 ANDA APP Pharmaceuticals, LLC 63323-734 N 63323-734-10
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 076207 ANDA APP Pharmaceuticals, LLC 63323-735 N 63323-735-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/10ML (3MG/ML)
Approval Date:May 17, 2002TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength90MG/10ML (9MG/ML)
Approval Date:May 17, 2002TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Mallinckrodt
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