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Profile for Tradename: HECTOROL

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Summary for Tradename: HECTOROL

Patents:2
Applicants:1
NDAs:2
Suppliers: see list3

Pharmacology for Tradename: HECTOROL

Ingredient-typeErgocalciferols
Drug ClassVitamin D2 Analog

Clinical Trials for: HECTOROL

A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Status: Completed Condition: Secondary Hyperparathyroidism

Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Status: Completed Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure

A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
Status: Completed Condition: Moderate to Severe Chronic Plaque Psoriasis

Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Status: Recruiting Condition: Chronic Kidney Disease; Kidney Transplantation

A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Status: Completed Condition: Chronic Kidney Disease, Stage 5; Secondary Hyperparathyroidism

Doxercalciferol in Recurrent Pediatric Solid Tumors
Status: Terminated Condition: Solid Tumors

A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Status: Completed Condition: Secondary Hyperparathyroidism

A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Status: Completed Condition: Secondary Hyperparathyroidism

Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Stage Three and Four
Status: Completed Condition: Secondary Hyperparathyroidism in Chronic Kidney Disease Stage 3 and 4

Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862Apr 23, 2004RXNo5,602,116<disabled><disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862Jun 9, 1999RXYes6,903,083<disabled>YYY<disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862Jun 9, 1999RXYes5,602,116<disabled><disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862Apr 23, 2004RXNo6,903,083<disabled>YYY<disabled>
Genzyme Corp
HECTOROL
doxercalciferol
INJECTABLE;INJECTION021027Apr 6, 2000RXNo5,602,116<disabled><disabled>
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Paragraph IV activity for: HECTOROL

Drugname Dosage Strength RLD Submissiondate
doxercalciferolInjection2 mcg/mL, 1 mL in 2 mL vialHectorol12/28/2011
doxercalciferolCapsules1 mcgHectorol2/12/2010
doxercalciferolCapsules0.5 mcg and 2.5 mcgHectorol3/25/2009
doxercalciferolInjection2 mcg/mL, 2 mL ampulesHectorol10/15/2007
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