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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204276

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NDA 204276 describes ERGOCALCIFEROL, which is a drug marketed by Chartwell Rx, Puracap Pharm Llc, Sigmapharm Labs Llc, Strides Pharma, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from seventeen 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-two suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.

Summary for 204276

Tradename:	ERGOCALCIFEROL
Applicant:	Puracap Pharm Llc
Ingredient:	ergocalciferol
Patents:	0

Pharmacology for NDA: 204276

Suppliers and Packaging for NDA: 204276

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	204276	ANDA	Epic Pharma LLC	42806-547	42806-547-01	100 CAPSULE in 1 BOTTLE (42806-547-01)
ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	204276	ANDA	Epic Pharma LLC	42806-547	42806-547-05	500 CAPSULE in 1 BOTTLE (42806-547-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50,000 IU
Approval Date:	Dec 7, 2018	TE:	AA	RLD:	No

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