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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 091412


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NDA 091412 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Caplin, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in seventeen NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 091412
Tradename:PARICALCITOL
Applicant:Chartwell Rx
Ingredient:paricalcitol
Patents:0
Pharmacology for NDA: 091412
Suppliers and Packaging for NDA: 091412
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol CAPSULE;ORAL 091412 ANDA Dr. Reddy's Laboratories Limited 55111-663 55111-663-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-01)
PARICALCITOL paricalcitol CAPSULE;ORAL 091412 ANDA Dr. Reddy's Laboratories Limited 55111-663 55111-663-05 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jun 24, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Jun 24, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Jun 24, 2014TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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