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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075419

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NDA 075419 describes ETODOLAC, which is a drug marketed by Ani Pharms Inc, Apotex, Chartwell Molecules, Eci Pharms Llc, Mylan, Sandoz, Taro, Watson Labs, Actavis Elizabeth, Teva, Watson Labs Florida, Zydus Pharms Usa Inc, Amneal Pharms Co, Apotex Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Oxford Pharms, Ranbaxy Labs Ltd, and Taro Pharm Inds, and is included in thirty-four NDAs. It is available from forty-two 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-two suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 075419
Tradename:ETODOLAC
Applicant:Apotex
Ingredient:etodolac
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075419
Medical Subject Heading (MeSH) Categories for 075419
Suppliers and Packaging for NDA: 075419
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac CAPSULE;ORAL 075419 ANDA AvKARE, Inc. 42291-404 N 42291-404-01
ETODOLAC etodolac CAPSULE;ORAL 075419 ANDA AvKARE, Inc. 42291-405 N 42291-405-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 28, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 28, 2000TE:ABRLD:No

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