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Generated: September 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207174

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NDA 207174 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Lotus Pharm Co Ltd, Marksans Pharma, Rising Pharms, 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 eighteen 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. Twenty suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 207174
Tradename:PARICALCITOL
Applicant:Accord Hlthcare
Ingredient:paricalcitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207174
Ingredient-typeCholecalciferol
Suppliers and Packaging for NDA: 207174
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 207174 NDA Accord Healthcare, Inc. 16729-310 16729-310-08 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-08) > 1 mL in 1 VIAL, SINGLE-DOSE
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 207174 NDA Accord Healthcare, Inc. 16729-310 16729-310-63 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-63) > 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Feb 4, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Feb 4, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Feb 4, 2016TE:APRLD:No

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