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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076174

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NDA 076174 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 thirty-nine suppliers. Additional details are available on the ETODOLAC profile page.

The generic ingredient in ETODOLAC is etodolac. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the etodolac profile page.

Summary for 076174

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076174

Medical Subject Heading (MeSH) Categories for 076174

Suppliers and Packaging for NDA: 076174

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 076174 ANDA NORTHSTAR RX LLC 16714-497 16714-497-01 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01)
ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 076174 ANDA NORTHSTAR RX LLC 16714-497 16714-497-02 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Mar 13, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Mar 13, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Mar 13, 2003TE:ABRLD:No


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