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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091101

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NDA 091101 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 091101
Tradename:DOXERCALCIFEROL
Applicant:Hikma Pharms
Ingredient:doxercalciferol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091101
Ingredient-typeErgocalciferols
Suppliers and Packaging for NDA: 091101
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 091101 ANDA West-Ward Pharmaceutical Corp. 0641-6154 N 0641-6154-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MCG/2ML (2MCG/ML)
Approval Date:Aug 30, 2013TE:APRLD:No

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