Details for New Drug Application (NDA): 078520

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

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/10ML (3MG/ML)
Approval Date:	Oct 31, 2008	TE:	AP2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	90MG/10ML (9MG/ML)
Approval Date:	Oct 31, 2008	TE:	AP2	RLD:	No

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