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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 Genzyme Corp and is included in two NDAs. It is available from four 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. There is one tentative approval for this compound. Additional details are available on the doxercalciferol profile page.

Summary for NDA: 020862

Genzyme Corp
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for NDA: 020862


Suppliers and Packaging for NDA: 020862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 020862 NDA REMEDYREPACK INC. 52125-085 52125-085-02 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (52125-085-02)
CAPSULE;ORAL 020862 NDA Genzyme Corporation 58468-0120 58468-0120-1 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (58468-0120-1)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Apr 23, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jul 13, 2009TE:ABRLD:No

Expired Orange Book Patents for NDA: 020862

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp
CAPSULE;ORAL020862-002Apr 23, 20045,602,116► subscribe
Genzyme Corp
CAPSULE;ORAL020862-001Jun 9, 19995,869,473► subscribe
Genzyme Corp
CAPSULE;ORAL020862-001Jun 9, 19995,707,980► subscribe
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