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Last Updated: November 2, 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
Yung Shin Pharm DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 205143-002 Feb 19, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 206771-002 Jun 12, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 204355-001 Jul 15, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200158-001 May 9, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 020607-002 Dec 24, 1997 ⤷  Sign Up ⤷  Sign Up
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Sign Up ⤷  Sign Up
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997 ⤷  Sign Up ⤷  Sign Up
Pfizer ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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