You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Johnson and Johnson
McKinsey
Merck
Dow

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202252


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 202252 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Ani Pharms Inc, Apotex, 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-five 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
Formulation / Manufacturing:see details
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Johnson and Johnson
AstraZeneca
Mallinckrodt
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.