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Details for New Drug Application (NDA): 021695

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NDA 021695 describes ANTARA (MICRONIZED), which is a drug marketed by Lupin Atlantis and is included in one NDA. It is available from two suppliers. There are four 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-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 021695

Tradename:
ANTARA (MICRONIZED)
Applicant:
Lupin Atlantis
Ingredient:
fenofibrate
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021695

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 PHARMA 27437-107 27437-107-06 30 CAPSULE in 1 BOTTLE (27437-107-06)
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL 021695 NDA LUPIN PHARMA 27437-107 27437-107-19 7 CAPSULE in 1 BOTTLE (27437-107-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Nov 30, 2004TE:ABRLD:No
Patent:7,101,574Patent Expiration:Aug 20, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:7,863,331Patent Expiration:Aug 8, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING HYPERCHOLESTEROLEMIAS WITH REDUCTION OF FOOD EFFECT
Patent:7,863,331Patent Expiration:Aug 8, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING HYPERTRIGLYCERIDEMIAS WITH REDUCTION OF FOOD EFFECT

Expired Orange Book Patents for NDA: 021695

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-001Nov 30, 20044,800,079► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 30, 20044,800,079► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-002Nov 30, 20044,800,079► subscribe
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