Last Updated: September 28, 2026

Details for New Drug Application (NDA): 018044

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NDA 018044 describes ROCALTROL, which is a drug marketed by Esjay Pharma and is included in two NDAs. It is available from one supplier. Additional details are available on the ROCALTROL profile page.

The generic ingredient in ROCALTROL is calcitriol. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for 018044

Tradename:	ROCALTROL
Applicant:	Esjay Pharma
Ingredient:	calcitriol
Patents:	0

Medical Subject Heading (MeSH) Categories for 018044

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MCG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018044

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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