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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Dow
Healthtrust
Covington
AstraZeneca
Daiichi Sankyo
US Department of Justice
Deloitte
Federal Trade Commission
Fuji
Mallinckrodt

Generated: December 18, 2017

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:1
Applicant:1
Ingredient:1
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 64980-228-50 1 BOTTLE in 1 CARTON (64980-228-50) > 50 CAPSULE in 1 BOTTLE
DOXERCALCIFEROL doxercalciferol CAPSULE;ORAL 201518 ANDA Rising Pharmaceuticals, Inc. 64980-229 64980-229-50 1 BOTTLE in 1 CARTON (64980-229-50) > 50 CAPSULE in 1 BOTTLE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Cerilliant
Cantor Fitzgerald
Queensland Health
QuintilesIMS
Chinese Patent Office
US Army
Novartis
AstraZeneca
Boehringer Ingelheim
Farmers Insurance

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