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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209798

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NDA 209798 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 209798

Tradename:	CALCITRIOL
Applicant:	Rising
Ingredient:	calcitriol
Patents:	0

Pharmacology for NDA: 209798

Medical Subject Heading (MeSH) Categories for 209798

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Suppliers and Packaging for NDA: 209798

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITRIOL	calcitriol	SOLUTION;ORAL	209798	ANDA	Rising Pharma Holdings, Inc.	64980-447	64980-447-15	1 BOTTLE, GLASS in 1 CARTON (64980-447-15) / 15 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MCG/ML
Approval Date:	Nov 21, 2018	TE:	AA	RLD:	No

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