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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
McKesson
Dow
Deloitte
Teva
Baxter
Mallinckrodt
Healthtrust
Farmers Insurance

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201518

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NDA 201518 describes DOXERCALCIFEROL, which is a drug marketed by Rising Pharms Inc, West-ward Pharms Int, Akorn Inc, Amneal Pharms Co, Hikma Pharms, and Sandoz Inc, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the DOXERCALCIFEROL profile page.

The generic ingredient in DOXERCALCIFEROL is doxercalciferol. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 201518
Tradename:DOXERCALCIFEROL
Applicant:Rising Pharms Inc
Ingredient:doxercalciferol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201518
Ingredient-typeErgocalciferols
Suppliers and Packaging for NDA: 201518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518 ANDA Rising Pharmaceuticals, Inc. 64980-228 N 64980-228-50
DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518 ANDA Rising Pharmaceuticals, Inc. 64980-229 N 64980-229-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Sep 9, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Sep 9, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MCG
Approval Date:Sep 9, 2016TE:ABRLD:No

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Cerilliant
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