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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205566

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NDA 205566 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Amerigen Pharms Ltd, Apotex Inc, Austarpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Rhodes Pharms, and Torrent, and is included in thirteen NDAs. It is available from sixteen 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-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 205566
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Glenmark Pharms Ltd
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205566
Medical Subject Heading (MeSH) Categories for 205566
Suppliers and Packaging for NDA: 205566
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 205566 ANDA Glenmark Pharmaceuticals Inc., USA 68462-580 68462-580-01 100 CAPSULE in 1 BOTTLE (68462-580-01)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 205566 ANDA Glenmark Pharmaceuticals Inc., USA 68462-581 68462-581-01 100 CAPSULE in 1 BOTTLE (68462-581-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Apr 7, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Apr 7, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Apr 7, 2017TE:ABRLD:No

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