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ARTHROTEC Drug Profile

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Arthrotec is a drug marketed by Gd Searle Llc and is included in one NDA. It is available from nine suppliers.

The generic ingredient in ARTHROTEC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for Tradename: ARTHROTEC

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list9
Bulk Api Vendors: see list145
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ARTHROTEC at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 1997RXNo► subscribe► subscribe
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 1997RXYes► subscribe► subscribe
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Expired Patents for Tradename: ARTHROTEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 19974,301,146► subscribe
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 19974,301,146► subscribe
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 19975,698,225► subscribe
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Paragraph IV activity for: ARTHROTEC

Drugname Dosage Strength RLD Submissiondate
diclofenac sodium and misoprostolDelayed-release Tablets50 mg/0.2 mgArthrotec6/29/2009
diclofenac sodium and misoprostolDelayed-release Tablets75 mg/0.2 mgArthrotec11/28/2008
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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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