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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Cantor Fitzgerald
Healthtrust
Moodys
Fish and Richardson
Mallinckrodt
Johnson and Johnson
Julphar
Chubb

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074903

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NDA 074903 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 074903
Tradename:ETODOLAC
Applicant:Sandoz
Ingredient:etodolac
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074903
Medical Subject Heading (MeSH) Categories for 074903
Suppliers and Packaging for NDA: 074903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET;ORAL 074903 ANDA Eon Labs, Inc. 0185-0675 0185-0675-10 1000 TABLET, COATED in 1 BOTTLE (0185-0675-10)
ETODOLAC etodolac TABLET;ORAL 074903 ANDA Eon Labs, Inc. 0185-0675 0185-0675-01 100 TABLET, COATED in 1 BOTTLE (0185-0675-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 11, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 19, 1999TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Fuji
Fish and Richardson
Queensland Health
Express Scripts
Citi
Merck
Harvard Business School

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