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Last Updated: March 18, 2024

Diclofenac sodium; misoprostol - Generic Drug Details


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Summary for diclofenac sodium; misoprostol
US Patents:0
Tradenames:2
Applicants:8
NDAs:8
Finished Product Suppliers / Packagers: 12
DailyMed Link:diclofenac sodium; misoprostol at DailyMed
Pharmacology for diclofenac sodium; misoprostol
Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM; MISOPROSTOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ARTHROTEC Delayed-release Tablets diclofenac sodium; misoprostol 50 mg/0.2 mg 020607 1 2009-06-29
ARTHROTEC Delayed-release Tablets diclofenac sodium; misoprostol 75 mg/0.2 mg 020607 1 2008-11-28

US Patents and Regulatory Information for diclofenac sodium; misoprostol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200158-001 May 9, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Yung Shin Pharm DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 205143-001 Feb 19, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 201089-002 Jul 9, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 206771-001 Jun 12, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Exela Holdings DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540-002 Mar 14, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for diclofenac sodium; misoprostol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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