Details for New Drug Application (NDA): 021606

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NDA 021606 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 021606

Tradename:	ZEMPLAR
Applicant:	Abbvie
Ingredient:	paricalcitol
Patents:	0

Pharmacology for NDA: 021606

Suppliers and Packaging for NDA: 021606

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606	NDA	AbbVie Inc.	0074-9036	0074-9036-30	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-9036-30)
ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606	NDA	AbbVie Inc.	0074-9037	0074-9037-30	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-9037-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MCG
Approval Date:	May 26, 2005	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MCG
Approval Date:	May 26, 2005	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 26, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021606

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-002	May 26, 2005	⤷ Sign Up	⤷ Sign Up
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-003	May 26, 2005	⤷ Sign Up	⤷ Sign Up
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-001	May 26, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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