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Generated: November 17, 2018

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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. There are two patents protecting this drug and three Paragraph IV challenges. 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. Twenty-one 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 020819
Ingredient-typeCholecalciferol
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
Patent:➤ Try a Free TrialPatent Expiration:Oct 8, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Oct 8, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Feb 1, 2000TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 8, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020819

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

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