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Details for New Drug Application (NDA): 021612

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NDA 021612 describes LIPOFEN, which is a drug marketed by Cipher Pharms Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the LIPOFEN profile page.

The generic ingredient in LIPOFEN 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: 021612

Tradename:
LIPOFEN
Applicant:
Cipher Pharms Inc
Ingredient:
fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021612

Suppliers and Packaging for NDA: 021612

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIPOFEN
fenofibrate
CAPSULE;ORAL 021612 NDA H2-Pharma, LLC 61269-210 61269-210-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-210-90)
LIPOFEN
fenofibrate
CAPSULE;ORAL 021612 NDA H2-Pharma, LLC 61269-212 61269-212-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-212-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 11, 2006TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 11, 2006TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 11, 2006TE:RLD:Yes

Expired Orange Book Patents for NDA: 021612

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cipher Pharms Inc
LIPOFEN
fenofibrate
CAPSULE;ORAL021612-001Jan 11, 20065,545,628► subscribe
Cipher Pharms Inc
LIPOFEN
fenofibrate
CAPSULE;ORAL021612-003Jan 11, 20065,545,628► subscribe
Cipher Pharms Inc
LIPOFEN
fenofibrate
CAPSULE;ORAL021612-002Jan 11, 20065,545,628► subscribe
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