BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Queensland Health
Citi
Mallinckrodt
Fish and Richardson
Julphar
Federal Trade Commission
QuintilesIMS
UBS
Cerilliant

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075009

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NDA 075009 describes ETODOLAC, which is a drug marketed by Ani Pharms Inc, Apotex, Chartwell Molecules, Eci Pharms Llc, Idt Australia Ltd, Mylan, Sandoz, Taro, Watson Labs, Actavis Elizabeth, Teva, Watson Labs Florida, Zydus Pharms Usa Inc, Apotex Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Oxford Pharms, Ranbaxy Labs Ltd, and Taro Pharm Inds, and is included in thirty-three NDAs. It is available from forty suppliers. Additional details are available on the ETODOLAC profile page.

The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 075009
Tradename:ETODOLAC
Applicant:Teva
Ingredient:etodolac
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075009
Medical Subject Heading (MeSH) Categories for 075009
Suppliers and Packaging for NDA: 075009
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET;ORAL 075009 ANDA Teva Pharmaceuticals USA, Inc. 0093-0892 0093-0892-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0892-01)
ETODOLAC etodolac TABLET;ORAL 075009 ANDA Teva Pharmaceuticals USA, Inc. 0093-1893 0093-1893-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-1893-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 26, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 28, 1999TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Medtronic
Argus Health
Mallinckrodt
Johnson and Johnson
Federal Trade Commission
Dow
US Army

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