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Generated: May 26, 2017

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Details for New Drug Application (NDA): 003444

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NDA 003444 describes DRISDOL, which is a drug marketed by Us Pharm Holdings and is included in one NDA. It is available from four suppliers. Additional details are available on the DRISDOL profile page.

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

Summary for NDA: 003444

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 003444

Ingredient-typeErgocalciferols

Suppliers and Packaging for NDA: 003444

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRISDOL
ergocalciferol
CAPSULE;ORAL 003444 NDA sanofi-aventis U.S. LLC 0024-0393 0024-0393-10 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0024-0393-10)
DRISDOL
ergocalciferol
CAPSULE;ORAL 003444 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-0251 0955-0251-10 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0955-0251-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50,000 IU
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes


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