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Generated: January 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207378

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NDA 207378 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 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 207378
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Invagen Pharms
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207378
Medical Subject Heading (MeSH) Categories for 207378
Suppliers and Packaging for NDA: 207378
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207378 ANDA Northstar Rx LLC 16714-739 16714-739-01 90 CAPSULE in 1 BOTTLE, PLASTIC (16714-739-01)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207378 ANDA Northstar Rx LLC 16714-739 16714-739-02 100 CAPSULE in 1 BOTTLE, PLASTIC (16714-739-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Mar 28, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Mar 28, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Mar 28, 2017TE:ABRLD:No

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