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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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US Department of Justice
Federal Trade Commission

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091433

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NDA 091433 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 091433
Applicant:West-ward Pharms Int
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091433
Suppliers and Packaging for NDA: 091433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 091433 ANDA West-Ward Pharmaceuticals Corp. 0054-0338 N 0054-0338-19
DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 091433 ANDA West-Ward Pharmaceuticals Corp. 0054-0339 N 0054-0339-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Sep 23, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jan 14, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MCG
Approval Date:Jan 14, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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