Details for New Drug Application (NDA): 021695

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NDA 021695 describes ANTARA (MICRONIZED), which is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ANTARA (MICRONIZED) profile page.

The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 021695

Tradename:	ANTARA (MICRONIZED)
Applicant:	Lupin
Ingredient:	fenofibrate
Patents:	2

Pharmacology for NDA: 021695

Medical Subject Heading (MeSH) Categories for 021695

Hypolipidemic Agents

Suppliers and Packaging for NDA: 021695

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA	Lupin Pharmaceuticals, Inc.	27437-109	27437-109-06	30 CAPSULE in 1 BOTTLE (27437-109-06)
ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695	NDA	Lupin Pharmaceuticals, Inc.	27437-110	27437-110-06	30 CAPSULE in 1 BOTTLE (27437-110-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	43MG
Approval Date:	Nov 30, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	87MG
Approval Date:	Nov 30, 2004	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	130MG
Approval Date:	Nov 30, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021695

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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