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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 201518

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NDA 201518 describes DOXERCALCIFEROL, which is a drug marketed by Hikma, Rising, Akorn Inc, Amneal, Gland Pharma Ltd, Hospira Inc, Lupin Ltd, Meitheal, Sandoz Inc, and Sun Pharm, and is included in thirteen NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 201518
Tradename:DOXERCALCIFEROL
Applicant:Rising
Ingredient:doxercalciferol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201518
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

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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