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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091134


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NDA 091134 describes ETODOLAC, which is a drug marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Ipca Labs Ltd, Mylan, Natco Pharma, Sandoz, Taro, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Abraxeolus, Adaptis, Amneal Pharms Co, Apotex Inc, Ivax Sub Teva Pharms, Oxford Pharms, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-nine 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 091134
Tradename:ETODOLAC
Applicant:Zydus Pharms
Ingredient:etodolac
Patents:0
Pharmacology for NDA: 091134
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 091134
Suppliers and Packaging for NDA: 091134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 091134 ANDA St. Mary's Medical Park Pharmacy 60760-298 60760-298-15 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-298-15)
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 091134 ANDA Proficient Rx LP 63187-374 63187-374-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Jan 23, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jan 23, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Jan 23, 2014TE:ABRLD:No

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