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Generated: April 21, 2019

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Details for New Drug Application (NDA): 021027

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NDA 021027 describes HECTOROL, which is a drug marketed by Sanofi and is included in two NDAs. It is available from two 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. Nine suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 021027
Tradename:HECTOROL
Applicant:Sanofi
Ingredient:doxercalciferol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021027
Suppliers and Packaging for NDA: 021027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HECTOROL doxercalciferol INJECTABLE;INJECTION 021027 NDA Genzyme Corporation 58468-0123 58468-0123-1 50 VIAL, SINGLE-USE in 1 BOX (58468-0123-1) > 2 mL in 1 VIAL, SINGLE-USE
HECTOROL doxercalciferol INJECTABLE;INJECTION 021027 NDA Genzyme Corporation 58468-0126 58468-0126-1 50 VIAL, SINGLE-USE in 1 BOX (58468-0126-1) > 1 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MCG/2ML (2MCG/ML)
Approval Date:Apr 6, 2000TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MCG/ML (2MCG/ML)
Approval Date:Apr 6, 2000TE:APRLD:Yes

Expired US Patents for NDA 021027

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-002 Apr 6, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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