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Last Updated: October 12, 2024

Details for New Drug Application (NDA): 213842


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NDA 213842 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 213842
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Alembic
Ingredient:fenofibrate
Patents:0
Pharmacology for NDA: 213842
Medical Subject Heading (MeSH) Categories for 213842
Suppliers and Packaging for NDA: 213842
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 213842 ANDA Alembic Pharmaceuticals Limited 46708-084 46708-084-30 30 CAPSULE in 1 BOTTLE (46708-084-30)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 213842 ANDA Alembic Pharmaceuticals Limited 46708-084 46708-084-31 100 CAPSULE in 1 BOTTLE (46708-084-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Oct 19, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Oct 19, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Oct 19, 2020TE:ABRLD:No

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