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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078520


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NDA 078520 describes PAMIDRONATE DISODIUM, which is a drug marketed by Aesgen, Am Regent, Areva Pharms, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Mn Pharms, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in fourteen NDAs. It is available from two 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. Two suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.
Summary for 078520
Tradename:PAMIDRONATE DISODIUM
Applicant:Mylan Labs Ltd
Ingredient:pamidronate disodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078520
Suppliers and Packaging for NDA: 078520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 078520 ANDA Mylan Institutional LLC 67457-430 67457-430-10 1 VIAL in 1 CARTON (67457-430-10) / 10 mL in 1 VIAL
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 078520 ANDA Mylan Institutional LLC 67457-446 67457-446-10 1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/10ML (3MG/ML)
Approval Date:Oct 31, 2008TE:AP2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength90MG/10ML (9MG/ML)
Approval Date:Oct 31, 2008TE:AP2RLD:No

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