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Details for New Drug Application (NDA): 202539

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NDA 202539 describes PARICALCITOL, which is a drug marketed by Sandoz Canada Inc, Eci Pharms Llc, Dr Reddys Labs Ltd, Hikma Pharms, Rising Pharms Inc, Amneal Pharms, Teva Pharms Usa, Bionpharma Inc, Marksans Pharma, Hospira Inc, Aurobindo Pharma Ltd, and Accord Hlthcare, and is included in thirteen NDAs. It is available from fifteen 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. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the paricalcitol profile page.

Summary for NDA: 202539

Tradename:
PARICALCITOL
Applicant:
Bionpharma Inc
Ingredient:
paricalcitol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202539

Ingredient-typeCholecalciferol

Suppliers and Packaging for NDA: 202539

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL
paricalcitol
CAPSULE;ORAL 202539 ANDA Banner Pharmacaps 10888-5001 10888-5001-2 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (10888-5001-2)
PARICALCITOL
paricalcitol
CAPSULE;ORAL 202539 ANDA Banner Pharmacaps 10888-5002 10888-5002-2 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (10888-5002-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Mar 27, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Mar 27, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Mar 27, 2014TE:ABRLD:No


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