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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202252


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NDA 202252 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, and Torrent, and is included in sixteen NDAs. It is available from seventeen 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 202252
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Apotex
Ingredient:fenofibrate
Patents:0
Pharmacology for NDA: 202252
Medical Subject Heading (MeSH) Categories for 202252
Suppliers and Packaging for NDA: 202252
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202252 ANDA Apotex Corp. 60505-3120 60505-3120-1 100 CAPSULE in 1 BOTTLE (60505-3120-1)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202252 ANDA Apotex Corp. 60505-3120 60505-3120-3 30 CAPSULE in 1 BOTTLE (60505-3120-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Jul 26, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Jul 26, 2013TE:ABRLD:No

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