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Generated: April 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090859

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NDA 090859 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, Rhodes Pharms, and Torrent, 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-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 090859
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Dr Reddys Labs Sa
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090859
Medical Subject Heading (MeSH) Categories for 090859
Suppliers and Packaging for NDA: 090859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859 ANDA Dr. Reddy's Laboratories Limited 55111-349 55111-349-01 100 CAPSULE in 1 BOTTLE (55111-349-01)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859 ANDA Dr. Reddy's Laboratories Limited 55111-349 55111-349-30 30 CAPSULE in 1 BOTTLE (55111-349-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Mar 1, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Mar 1, 2012TE:ABRLD:No

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