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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 204948


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NDA 204948 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in seventeen NDAs. It is available from eleven suppliers. Additional details are available on the PARICALCITOL profile page.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 204948
Tradename:PARICALCITOL
Applicant:Marksans Pharma
Ingredient:paricalcitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204948
Suppliers and Packaging for NDA: 204948
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol CAPSULE;ORAL 204948 ANDA MARKSANS PHARMA LIMITED 25000-012 25000-012-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-012-03)
PARICALCITOL paricalcitol CAPSULE;ORAL 204948 ANDA MARKSANS PHARMA LIMITED 25000-012 25000-012-50 4 BAG in 1 BOX (25000-012-50) / 10000 CAPSULE, LIQUID FILLED in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Oct 7, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Oct 7, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Oct 7, 2016TE:ABRLD:No

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