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Generated: November 19, 2018

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Details for New Drug Application (NDA): 020862

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NDA 020862 describes HECTOROL, which is a drug marketed by Sanofi and is included in two NDAs. It is available from three suppliers. Additional details are available on the HECTOROL profile page.

The generic ingredient in HECTOROL is doxercalciferol. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 020862
Tradename:HECTOROL
Applicant:Sanofi
Ingredient:doxercalciferol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020862
Ingredient-typeErgocalciferols
Suppliers and Packaging for NDA: 020862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HECTOROL doxercalciferol CAPSULE;ORAL 020862 NDA Winthrop U.S. 0955-1720 0955-1720-50 1 BOTTLE in 1 CARTON (0955-1720-50) > 50 CAPSULE in 1 BOTTLE
HECTOROL doxercalciferol CAPSULE;ORAL 020862 NDA Winthrop U.S. 0955-1721 0955-1721-50 1 BOTTLE in 1 CARTON (0955-1721-50) > 50 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MCG
Approval Date:Jun 9, 1999TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Apr 23, 2004TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jul 13, 2009TE:ABRLD:Yes

Expired US Patents for NDA 020862

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-003 Jul 13, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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