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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-six drug master file entries for this compound. Seventeen 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
Formulation / Manufacturing:see details

Clinical Trials for: ARTHROTEC

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<disabled><disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 1997RXYes<disabled><disabled>
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Expired Patents for Tradename: ARTHROTEC

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 19974,301,146<disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 19975,601,843<disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 19975,698,225<disabled>
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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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