.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202579

« Back to Dashboard
NDA 202579 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Apotex Inc, Teva, Dr Reddys Labs Sa, Impax Labs, and Mylan Pharms Inc, and is included in six NDAs. It is available from twelve suppliers. Additional details are available on the FENOFIBRATE (MICRONIZED) profile page.

The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 202579

Tradename:
FENOFIBRATE (MICRONIZED)
Applicant:
Mylan Pharms Inc
Ingredient:
fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

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

Summary for product number 002

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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc