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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 091004

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NDA 091004 describes ERGOCALCIFEROL, which is a drug marketed by Chartwell Rx, Onesource Specialty, Puracap Pharm Llc, Sigmapharm Labs Llc, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from twenty suppliers. Additional details are available on the ERGOCALCIFEROL profile page.

The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.

Summary for 091004

Tradename:	ERGOCALCIFEROL
Applicant:	Sigmapharm Labs Llc
Ingredient:	ergocalciferol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50,000 IU
Approval Date:	Jul 14, 2010	TE:		RLD:	No

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