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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205917


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NDA 205917 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in seventeen NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 205917
Tradename:PARICALCITOL
Applicant:Hikma Pharms
Ingredient:paricalcitol
Patents:0
Pharmacology for NDA: 205917
Suppliers and Packaging for NDA: 205917
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917 NDA West-Ward Pharmaceuticals Corp 0143-9596 0143-9596-25 25 VIAL, MULTI-DOSE in 1 CARTON (0143-9596-25) / 2 mL in 1 VIAL, MULTI-DOSE (0143-9596-01)
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917 NDA West-Ward Pharmaceuticals Corp 0143-9624 0143-9624-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9624-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0143-9624-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

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