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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 075836

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NDA 075836 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, 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 075836

Tradename:	CALCITRIOL
Applicant:	Fresenius Kabi Usa
Ingredient:	calcitriol
Patents:	0

Medical Subject Heading (MeSH) Categories for 075836

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.001MG/ML
Approval Date:	Dec 31, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.002MG/ML
Approval Date:	Dec 31, 2002	TE:		RLD:	No

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