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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 021113

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NDA 021113 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 021113

Tradename:	PAMIDRONATE DISODIUM
Applicant:	Hikma
Ingredient:	pamidronate disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/10ML (3MG/ML)
Approval Date:	Mar 4, 2002	TE:	AP1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	90MG/10ML (9MG/ML)
Approval Date:	Mar 4, 2002	TE:	AP1	RLD:	Yes

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