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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 076004


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NDA 076004 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, Amneal Pharms Co, Apotex Inc, Edenbridge Pharms, Ivax Sub Teva Pharms, Oxford Pharms, Pangea, 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 076004
Tradename:ETODOLAC
Applicant:Apotex Inc
Ingredient:etodolac
Patents:0
Pharmacology for NDA: 076004
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 076004
Suppliers and Packaging for NDA: 076004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET;ORAL 076004 ANDA PD-Rx Pharmaceuticals, Inc. 43063-578 43063-578-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-578-20)
ETODOLAC etodolac TABLET;ORAL 076004 ANDA PD-Rx Pharmaceuticals, Inc. 43063-671 43063-671-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-671-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Dec 3, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 3, 2002TE:ABRLD:No

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