Details for New Drug Application (NDA): 020036

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NDA 020036 describes AREDIA, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the AREDIA profile page.

The generic ingredient in AREDIA 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 020036

Tradename:	AREDIA
Applicant:	Novartis
Ingredient:	pamidronate disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 1991	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	60MG/VIAL
Approval Date:	May 6, 1993	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	90MG/VIAL
Approval Date:	May 6, 1993	TE:		RLD:	No

Expired US Patents for NDA 020036

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-001	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-003	May 6, 1993	⤷ Sign Up	⤷ Sign Up
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-004	May 6, 1993	⤷ Sign Up	⤷ Sign Up
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-004	May 6, 1993	⤷ Sign Up	⤷ Sign Up
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-003	May 6, 1993	⤷ Sign Up	⤷ Sign Up
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-001	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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