Details for New Drug Application (NDA): 018312

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NDA 018312 describes CALDEROL, which is a drug marketed by Organon Usa Inc and is included in one NDA. Additional details are available on the CALDEROL profile page.

The generic ingredient in CALDEROL is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

Summary for 018312

Tradename:	CALDEROL
Applicant:	Organon Usa Inc
Ingredient:	calcifediol
Patents:	0

Medical Subject Heading (MeSH) Categories for 018312

Bone Density Conservation Agents
Vitamins

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.02MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.05MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 018312

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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