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Generated: April 18, 2019

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Details for New Drug Application (NDA): 202579

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NDA 202579 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 202579
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Mylan Pharms Inc
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202579
Medical Subject Heading (MeSH) Categories for 202579
Suppliers and Packaging for NDA: 202579
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202579 ANDA Mylan Pharmaceuticals Inc. 0378-6088 0378-6088-93 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-6088-93)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202579 ANDA Mylan Pharmaceuticals Inc. 0378-6089 0378-6089-77 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6089-77)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Jan 10, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Jan 10, 2013TE:ABRLD:No

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