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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 074903


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NDA 074903 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 074903
Tradename:ETODOLAC
Applicant:Sandoz
Ingredient:etodolac
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074903
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 074903
Suppliers and Packaging for NDA: 074903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET;ORAL 074903 ANDA Eon Labs, Inc. 0185-0675 0185-0675-01 100 TABLET, COATED in 1 BOTTLE (0185-0675-01)
ETODOLAC etodolac TABLET;ORAL 074903 ANDA Eon Labs, Inc. 0185-0675 0185-0675-10 1000 TABLET, COATED in 1 BOTTLE (0185-0675-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 11, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 19, 1999TE:ABRLD:No

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