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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 201748


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NDA 201748 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, and Torrent, and is included in forty-six NDAs. It is available from forty-five suppliers. Additional details are available on the FENOFIBRATE profile page.

The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 201748
Tradename:FENOFIBRATE
Applicant:Sun Pharm Inds Ltd
Ingredient:fenofibrate
Patents:0
Pharmacology for NDA: 201748
Medical Subject Heading (MeSH) Categories for 201748
Suppliers and Packaging for NDA: 201748
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate CAPSULE;ORAL 201748 ANDA Sun Pharmaceutical Industries, Inc. 63304-443 63304-443-05 500 CAPSULE in 1 BOTTLE (63304-443-05)
FENOFIBRATE fenofibrate CAPSULE;ORAL 201748 ANDA Sun Pharmaceutical Industries, Inc. 63304-443 63304-443-30 30 CAPSULE in 1 BOTTLE (63304-443-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Oct 31, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Oct 31, 2014TE:ABRLD:No

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