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Last Updated: May 25, 2020

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Details for New Drug Application (NDA): 020819


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NDA 020819 describes ZEMPLAR, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. Additional details are available on the ZEMPLAR profile page.

The generic ingredient in ZEMPLAR is paricalcitol. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 020819
Tradename:ZEMPLAR
Applicant:Abbvie
Ingredient:paricalcitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020819
Suppliers and Packaging for NDA: 020819
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819 NDA AbbVie Inc. 0074-1658 0074-1658-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0074-1658-01) > 1 mL in 1 VIAL, SINGLE-DOSE
ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819 NDA AbbVie Inc. 0074-1658 0074-1658-05 25 VIAL, MULTI-DOSE in 1 TRAY (0074-1658-05) > 2 mL in 1 VIAL, MULTI-DOSE
Paragraph IV (Patent) Challenges for 020819
Tradename Dosage Ingredient NDA Submissiondate
ZEMPLAR SOLUTION;INTRAVENOUS paricalcitol 020819 2008-11-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Apr 17, 1998TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Feb 1, 2000TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Feb 1, 2000TE:APRLD:Yes

Expired US Patents for NDA 020819

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-003 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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