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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078942

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NDA 078942 describes PAMIDRONATE DISODIUM, which is a drug marketed by Mn Pharms, Sun Pharma Global, Fresenius Kabi Usa, West-ward Pharms Int, Mylan Labs Ltd, Areva Pharms, Hospira, Luitpold, Teva Pharms Usa, Pliva Lachema, Sagent Pharms, and Aesgen, and is included in fourteen NDAs. It is available from seven 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. Seven suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.

Summary for NDA: 078942

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078942

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 078942

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM
pamidronate disodium
INJECTABLE;INJECTION 078942 ANDA American Regent, Inc. 0517-0745 0517-0745-01 1 VIAL in 1 CARTON (0517-0745-01) > 10 mL in 1 VIAL
PAMIDRONATE DISODIUM
pamidronate disodium
INJECTABLE;INJECTION 078942 ANDA American Regent, Inc. 0517-0746 0517-0746-01 1 VIAL in 1 CARTON (0517-0746-01) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/10ML (3MG/ML)
Approval Date:Jul 25, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength90MG/10ML (9MG/ML)
Approval Date:Jul 25, 2008TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
Accenture
Novartis
Queensland Health
Cantor Fitzgerald
Medtronic
Baxter
US Department of Justice
Chubb
Mallinckrodt

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