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Last Updated: June 25, 2022

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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018312

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.02MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.05MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired US Patents for NDA 018312

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

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