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Serving leading biopharmaceutical companies globally:

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Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091134

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NDA 091134 describes ETODOLAC, which is a drug marketed by Ani Pharms Inc, Apotex, Chartwell Molecules, Eci Pharms Llc, Idt Australia Ltd, Mylan, Sandoz, Taro, Watson Labs, Actavis Elizabeth, Teva, Watson Labs Florida, Zydus Pharms Usa Inc, Apotex Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Oxford Pharms, Ranbaxy Labs Ltd, and Taro Pharm Inds, and is included in thirty-three NDAs. It is available from forty 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. Forty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 091134
Tradename:ETODOLAC
Applicant:Zydus Pharms Usa Inc
Ingredient:etodolac
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091134
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 A-S Medication Solutions 50090-1317 50090-1317-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1317-1)
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 091134 ANDA A-S Medication Solutions 50090-1317 50090-1317-0 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1317-0)

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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