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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210801


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NDA 210801 describes DOXERCALCIFEROL, which is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm, and is included in sixteen NDAs. It is available from nine 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 210801
Tradename:DOXERCALCIFEROL
Applicant:Lupin Ltd
Ingredient:doxercalciferol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210801
Suppliers and Packaging for NDA: 210801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 210801 ANDA Lupin Pharmaceuticals, Inc. 68180-718 68180-718-52 50 VIAL, MULTI-DOSE in 1 CARTON (68180-718-52) / 2 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MCG/2ML (2MCG/ML)
Approval Date:Nov 1, 2018TE:APRLD:No

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