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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203929

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NDA 203929 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 203929
Tradename:DOXERCALCIFEROL
Applicant:Akorn Inc
Ingredient:doxercalciferol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203929
Ingredient-typeErgocalciferols
Suppliers and Packaging for NDA: 203929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929 ANDA Akorn, Inc. 17478-987 17478-987-11 10 VIAL, SINGLE-USE in 1 CARTON (17478-987-11) > 1 mL in 1 VIAL, SINGLE-USE (17478-987-01)
DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 203929 ANDA Akorn, Inc. 17478-987 17478-987-21 25 VIAL, SINGLE-USE in 1 CARTON (17478-987-21) > 1 mL in 1 VIAL, SINGLE-USE (17478-987-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MCG/2ML (2MCG/ML)
Approval Date:May 7, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MCG/ML (2MCG/ML)
Approval Date:Mar 28, 2016TE:APRLD:No

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