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Details for New Drug Application (NDA): 076153

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NDA 076153 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: 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 0703-4075-51 1 VIAL, SINGLE-USE in 1 CARTON (0703-4075-51) > 10 mL in 1 VIAL, SINGLE-USE
PAMIDRONATE DISODIUM
pamidronate disodium
INJECTABLE;INJECTION 076153 ANDA Teva Parenteral Medicines, Inc. 0703-4085 0703-4085-51 1 VIAL, SINGLE-USE in 1 CARTON (0703-4085-51) > 10 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

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

Summary 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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