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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077433

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NDA 077433 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 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 077433

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

Pharmacology for NDA: 077433

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 077433

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 077433 ANDA Areva Pharmaceuticals Inc. 59923-601 59923-601-10 1 VIAL, SINGLE-DOSE in 1 CARTON (59923-601-10) > 10 mL in 1 VIAL, SINGLE-DOSE
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 077433 ANDA Areva Pharmaceuticals Inc. 59923-602 59923-602-10 1 VIAL, SINGLE-DOSE in 1 CARTON (59923-602-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/VIAL
Approval Date:Nov 26, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength60MG/VIAL
Approval Date:Nov 26, 2008TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength90MG/VIAL
Approval Date:Nov 26, 2008TE:APRLD:No


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