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Details for New Drug Application (NDA): 206710

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NDA 206710 describes PARICALCITOL, which is a drug marketed by Sandoz Canada Inc, Lotus Pharm Co Ltd, 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 fourteen 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. Seventeen 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: 206710

Lotus Pharm Co Ltd
Therapeutic Class:Metabolic Bone Disease Agents

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Feb 24, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Feb 24, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Feb 24, 2016TE:ABRLD:No

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