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 one supplier. 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. Twelve 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

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

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

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

Expired US Patents for NDA 020819

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

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