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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204019

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NDA 204019 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: 204019

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

Pharmacology for NDA: 204019

Suppliers and Packaging for NDA: 204019

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE
fenofibrate
TABLET;ORAL 204019 ANDA Proficient Rx LP 63187-681 63187-681-30 30 TABLET in 1 BOTTLE (63187-681-30)
FENOFIBRATE
fenofibrate
TABLET;ORAL 204019 ANDA Proficient Rx LP 63187-681 63187-681-60 60 TABLET in 1 BOTTLE (63187-681-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Aug 17, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Aug 17, 2015TE:ABRLD:No


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