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Generated: June 26, 2019

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Details for New Drug Application (NDA): 206699

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NDA 206699 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, Teva Pharms Usa, Accord Hlthcare, Akorn, Amneal Pharms Co, Dr Reddys, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in seventeen NDAs. It is available from twenty 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-two suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 206699
Tradename:PARICALCITOL
Applicant:Amneal Pharms Co
Ingredient:paricalcitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206699
Suppliers and Packaging for NDA: 206699
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 206699 ANDA Amneal Biosciences LLC 70121-1033 70121-1033-7 10 CARTON in 1 CARTON (70121-1033-7) > 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1033-5) > 1 mL in 1 VIAL, SINGLE-DOSE (70121-1033-1)
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 206699 ANDA Amneal Biosciences LLC 70121-1034 70121-1034-7 10 CARTON in 1 CARTON (70121-1034-7) > 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1034-5) > 1 mL in 1 VIAL, SINGLE-DOSE (70121-1034-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Mar 9, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Mar 9, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Mar 9, 2017TE:APRLD:No

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