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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203289

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NDA 203289 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 203289

Tradename:	CALCITRIOL
Applicant:	Amneal Pharms
Ingredient:	calcitriol
Patents:	0

Pharmacology for NDA: 203289

Medical Subject Heading (MeSH) Categories for 203289

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Suppliers and Packaging for NDA: 203289

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITRIOL	calcitriol	CAPSULE;ORAL	203289	ANDA	Amneal Pharmaceuticals LLC	65162-519	65162-519-03	30 CAPSULE in 1 BOTTLE (65162-519-03)
CALCITRIOL	calcitriol	CAPSULE;ORAL	203289	ANDA	Amneal Pharmaceuticals LLC	65162-519	65162-519-10	100 CAPSULE in 1 BOTTLE (65162-519-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Jun 14, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MCG
Approval Date:	Jun 14, 2017	TE:	AB	RLD:	No

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