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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 077433

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NDA 077433 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 077433

Tradename:	PAMIDRONATE DISODIUM
Applicant:	Areva Pharms
Ingredient:	pamidronate disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/VIAL
Approval Date:	Nov 26, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	60MG/VIAL
Approval Date:	Nov 26, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	90MG/VIAL
Approval Date:	Nov 26, 2008	TE:	AP	RLD:	No

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