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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078066

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NDA 078066 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Onesource Specialty, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Anda Repository, and Rising, and is included in eighteen NDAs. It is available from twenty suppliers. Additional details are available on the CALCITRIOL profile page.

The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for 078066

Tradename:	CALCITRIOL
Applicant:	Long Grove Pharms
Ingredient:	calcitriol
Patents:	0

Medical Subject Heading (MeSH) Categories for 078066

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.001MG/ML
Approval Date:	Jan 29, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.002MG/ML
Approval Date:	Jan 29, 2008	TE:		RLD:	No

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