Details for New Drug Application (NDA): 020819

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. Fourteen 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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.005MG/ML (0.005MG/ML)
Approval Date:	Apr 17, 1998	TE:	AP	RLD:	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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.002MG/ML (0.002MG/ML)
Approval Date:	Feb 1, 2000	TE:	AP	RLD:	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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.01MG/2ML (0.005MG/ML)
Approval Date:	Feb 1, 2000	TE:	AP	RLD:	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	020819-003	Feb 1, 2000
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-003	Feb 1, 2000
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998

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