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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090829

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NDA 090829 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Caplin, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in seventeen NDAs. It is available from ten suppliers. Additional details are available on the PARICALCITOL profile page.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.

Summary for 090829

Tradename:	PARICALCITOL
Applicant:	Teva Pharms Usa
Ingredient:	paricalcitol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MCG
Approval Date:	Sep 27, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MCG
Approval Date:	Sep 27, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	4MCG
Approval Date:	Sep 27, 2013	TE:	AB	RLD:	No

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