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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. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: diclofenac sodium; misoprostol

Drug Master File Entries: see list46
Suppliers / Packaging: see list25

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gd Searle Llc
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 1997RXNo<disabled><disabled>
Actavis Labs Fl Inc
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-001Jul 9, 2012RXNo<disabled><disabled>
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-001May 9, 2013RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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