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Generated: December 13, 2017

DrugPatentWatch Database Preview

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 Inc, Dr Reddys Labs Ltd, Eci Pharms Llc, Marksans Pharma, Rising Pharms Inc, Teva Pharms Usa, Accord Hlthcare, Akorn, Amneal Pharms Co, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in sixteen NDAs. It is available from sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.

Summary for 091412

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091412

Ingredient-typeCholecalciferol

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 55111-663-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-30)
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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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