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Details for Generic Name: diclofenac sodium; misoprostol

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Diclofenac sodium; misoprostol is the generic ingredient in two branded drugs marketed by Gd Searle Llc, Actavis Labs Fl Inc, Eagle Pharms, and Sandoz, and is included in four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fourty-six drug master file entries for diclofenac sodium; misoprostol. Eight suppliers are listed for this compound.

Summary for Generic Name: diclofenac sodium; misoprostol

Tradenames:2
Patents:1
Applicants:4
NDAs:4
Drug Master File Entries: see list46
Suppliers: see list8

Clinical Trials for: diclofenac sodium; misoprostol

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
Status: Terminated Condition: Gastric Ulcer

Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Status: Recruiting Condition: Lumbar Spinal Stenosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200540Mar 14, 2014RXNo<disabled><disabled>
Sandoz
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158May 9, 2013RXNo<disabled><disabled>
Actavis Labs Fl Inc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089Jul 9, 2012RXNo<disabled><disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607Dec 24, 1997RXNo5,601,843<disabled><disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607Dec 24, 1997RXYes5,601,843<disabled><disabled>
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