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Generated: January 19, 2019

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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 one supplier. Additional details are available on the DRISDOL profile page.

The generic ingredient in DRISDOL is ergocalciferol. There are six drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 003444
Tradename:DRISDOL
Applicant:Us Pharm Holdings
Ingredient:ergocalciferol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 003444
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 Validus Pharmaceuticals LLC 30698-493 30698-493-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (30698-493-01)

Profile 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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