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Last Updated: May 19, 2022

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. Sixteen 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Apr 17, 1998TE:APRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2023
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Feb 1, 2000TE:APRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2023
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Feb 1, 2000TE:APRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2023
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Expired US Patents for NDA 020819

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

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