Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078942

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NDA 078942 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 is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.

Summary for 078942

Tradename:	PAMIDRONATE DISODIUM
Applicant:	Am Regent
Ingredient:	pamidronate disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	30MG/10ML (3MG/ML)
Approval Date:	Jul 25, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	90MG/10ML (9MG/ML)
Approval Date:	Jul 25, 2008	TE:		RLD:	No

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