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Diclofenac sodium; misoprostol - Generic Drug Details

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Diclofenac sodium; misoprostol is the generic ingredient in two branded drugs marketed by Gd Searle Llc, Exela Pharma Scs Llc, Sandoz, and Actavis Labs Fl Inc, 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. Seventeen suppliers are listed for this compound.

Summary for Generic Name: diclofenac sodium; misoprostol

Tradenames:2
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list46
Suppliers / Packaging: see list17
Formulation / Manufacturing:see details

Clinical Trials for: diclofenac sodium; misoprostol

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;ORAL020607-002Dec 24, 1997RXYes<disabled><disabled>
Actavis Labs Fl Inc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012RXNo<disabled><disabled>
Exela Pharma Scs Llc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200540-002Mar 14, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: diclofenac sodium; misoprostol

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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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