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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208834


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NDA 208834 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, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-seven NDAs. It is available from thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 208834
Tradename:ETODOLAC
Applicant:Amneal Pharms Co
Ingredient:etodolac
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208834
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 208834
Suppliers and Packaging for NDA: 208834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET;ORAL 208834 ANDA A-S Medication Solutions 50090-3963 50090-3963-0 14 TABLET, FILM COATED in 1 BOTTLE (50090-3963-0)
ETODOLAC etodolac TABLET;ORAL 208834 ANDA A-S Medication Solutions 50090-3963 50090-3963-1 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3963-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jun 7, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 7, 2018TE:ABRLD:No

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