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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 080704

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NDA 080704 describes VITAMIN D, which is a drug marketed by Bionpharma, Chartwell Molecular, Chase Chem, Everylife, Impax Labs, Vitarine, and West Ward, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the VITAMIN D profile page.

The generic ingredient in VITAMIN D 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 080704

Tradename:	VITAMIN D
Applicant:	Bionpharma
Ingredient:	ergocalciferol
Patents:	0

Pharmacology for NDA: 080704

Suppliers and Packaging for NDA: 080704

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VITAMIN D	ergocalciferol	CAPSULE;ORAL	080704	ANDA	AvKARE	42291-266	42291-266-01	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-266-01)
VITAMIN D	ergocalciferol	CAPSULE;ORAL	080704	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-711	43063-711-12	12 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43063-711-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50,000 IU
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	RLD:	No

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