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Generated: April 24, 2017

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Diclofenac sodium; misoprostol - Generic Drug Details

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What are the generic sources for diclofenac sodium; misoprostol and what is the scope of patent protection?

Diclofenac sodium; misoprostol
is the generic ingredient in two branded drugs marketed by Gd Searle Llc, Exela Holdings, Sandoz, Actavis Labs Fl Inc, and Amneal Pharms, and is included in five 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 forty-seven drug master file entries for diclofenac sodium; misoprostol. Nineteen suppliers are listed for this compound.

Summary for Generic Name: diclofenac sodium; misoprostol

Drug Master File Entries: see list47
Suppliers / Packagers: see list19
Clinical Trials: see list1,060
Drug Prices:see low prices
DailyMed Link:diclofenac sodium; misoprostol at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL203995-002Nov 25, 2016ABRXNoNo► Subscribe► Subscribe
Actavis Labs Fl Inc
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012ABRXNoNo► Subscribe► Subscribe
Amneal Pharms
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL203995-001Nov 25, 2016ABRXNoNo► Subscribe► Subscribe
Gd Searle Llc
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 1997ABRXYesNo► Subscribe► Subscribe
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-001May 9, 2013ABRXNoNo► Subscribe► Subscribe
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