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Boehringer Ingelheim
Johnson and Johnson

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202252

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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
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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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