Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207564

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NDA 207564 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 207564
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Novast Labs
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207564
Medical Subject Heading (MeSH) Categories for 207564
Suppliers and Packaging for NDA: 207564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207564 ANDA Ingenus Pharmaceuticals, LLC 50742-201 50742-201-01 100 CAPSULE in 1 BOTTLE (50742-201-01)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207564 ANDA Ingenus Pharmaceuticals, LLC 50742-201 50742-201-05 500 CAPSULE in 1 BOTTLE (50742-201-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Apr 19, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Apr 19, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Apr 19, 2019TE:ABRLD:No

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