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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090856

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NDA 090856 describes FENOFIBRATE, which is a drug marketed by Cipla Ltd, Impax Labs, Valeant Pharms North, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Rhodes Pharms, Sun Pharm Inds Ltd, Mylan Pharms Inc, Hetero Labs Ltd Iii, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-one NDAs. It is available from thirty-four 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-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 090856

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090856

Suppliers and Packaging for NDA: 090856

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE
fenofibrate
TABLET;ORAL 090856 ANDA AvPAK 50268-310 50268-310-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-310-12) > 1 TABLET in 1 BLISTER PACK (50268-310-11)
FENOFIBRATE
fenofibrate
TABLET;ORAL 090856 ANDA AvPAK 50268-311 50268-311-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-311-12) > 1 TABLET in 1 BLISTER PACK (50268-311-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:Dec 23, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength145MG
Approval Date:Dec 23, 2011TE:ABRLD:No


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