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Last Updated: September 27, 2021

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Details for New Drug Application (NDA): 074842

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NDA 074842 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 074842
Applicant:Chartwell Molecules
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074842

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 17, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 17, 1997TE:RLD:No

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