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Generated: November 12, 2018

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Details for New Drug Application (NDA): 075868

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NDA 075868 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Amerigen Pharms Ltd, Apotex Inc, Cnty Line Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Rhodes Pharms, and Torrent Pharms Ltd, and is included in twelve NDAs. It is available from nineteen suppliers. Additional details are available on the FENOFIBRATE (MICRONIZED) profile page.

The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 075868
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Impax Labs
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075868
Medical Subject Heading (MeSH) Categories for 075868
Suppliers and Packaging for NDA: 075868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 075868 ANDA Impax Generics 0115-0511 0115-0511-01 100 CAPSULE in 1 BOTTLE (0115-0511-01)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 075868 ANDA Impax Generics 0115-0522 0115-0522-01 100 CAPSULE in 1 BOTTLE (0115-0522-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Oct 27, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Oct 27, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Oct 27, 2003TE:ABRLD:No

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