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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210782

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NDA 210782 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 210782
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Torrent
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210782
Medical Subject Heading (MeSH) Categories for 210782
Suppliers and Packaging for NDA: 210782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 210782 ANDA Torrent Pharmaceuticals Limited 13668-438 13668-438-01 100 CAPSULE in 1 BOTTLE (13668-438-01)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 210782 ANDA Torrent Pharmaceuticals Limited 13668-438 13668-438-05 500 CAPSULE in 1 BOTTLE (13668-438-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Jun 26, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Jun 26, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jun 26, 2018TE:ABRLD:No

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