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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075078

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NDA 075078 describes ETODOLAC, which is a drug marketed by Sandoz, Apotex Inc, Mylan Pharms Inc, Teva, Mylan, Apotex, Oxford Pharms, Ani Pharms Inc, Ranbaxy Labs Ltd, Eci Pharms Llc, Watson Labs Florida, Zydus Pharms Usa Inc, Idt Australia Ltd, Chartwell Molecules, Watson Labs, Taro, Taro Pharm Inds, Ivax Sub Teva Pharms, and Actavis Elizabeth, 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 075078

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

Pharmacology for NDA: 075078

Medical Subject Heading (MeSH) Categories for 075078

Suppliers and Packaging for NDA: 075078

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETODOLAC
etodolac
CAPSULE;ORAL 075078 ANDA KAISER FOUNDATION HOSPITALS 0179-1579 0179-1579-70 30 CAPSULE in 1 BOX, UNIT-DOSE (0179-1579-70)
ETODOLAC
etodolac
CAPSULE;ORAL 075078 ANDA STAT Rx USA LLC 16590-488 16590-488-21 21 CAPSULE in 1 BOTTLE (16590-488-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Apr 30, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Apr 30, 1998TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Dow
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US Department of Justice
QuintilesIMS
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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