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Last Updated: August 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075665


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NDA 075665 describes ETODOLAC, which is a drug marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Mylan, Sandoz, Taro, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Amneal Pharms Co, Apotex Inc, Edenbridge Pharms, Ivax Sub Teva Pharms, Oxford Pharms, Pharmgen, Ranbaxy Labs Ltd, Taro Pharm Inds, and Watson Labs, and is included in thirty-seven NDAs. It is available from twenty-nine 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 075665
Tradename:ETODOLAC
Applicant:Teva
Ingredient:etodolac
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075665
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 075665
Suppliers and Packaging for NDA: 075665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 075665 ANDA Teva Pharmaceuticals USA, Inc. 0093-1118 0093-1118-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1118-01)
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 075665 ANDA Teva Pharmaceuticals USA, Inc. 0093-1122 0093-1122-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1122-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Jul 31, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 31, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Feb 5, 2001TE:ABRLD:No

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