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Last Updated: December 14, 2019

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Details for New Drug Application (NDA): 020607

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NDA 020607 describes ARTHROTEC, which is a drug marketed by Gd Searle Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the ARTHROTEC profile page.

The generic ingredient in ARTHROTEC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 020607
Tradename:ARTHROTEC
Applicant:Gd Searle Llc
Ingredient:diclofenac sodium; misoprostol
Patents:0
Pharmacology for NDA: 020607
Suppliers and Packaging for NDA: 020607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1411 0025-1411-34 100 TABLET, FILM COATED in 1 CARTON (0025-1411-34)
ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1411 0025-1411-60 60 TABLET, FILM COATED in 1 BOTTLE (0025-1411-60)
Paragraph IV (Patent) Challenges for 020607
Tradename Dosage Ingredient NDA Submissiondate
ARTHROTEC TABLET, DELAYED RELEASE;ORAL diclofenac sodium; misoprostol 020607 2009-06-29
ARTHROTEC TABLET, DELAYED RELEASE;ORAL diclofenac sodium; misoprostol 020607 2008-11-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG;0.2MG
Approval Date:Dec 24, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG;0.2MG
Approval Date:Dec 24, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020607

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997   Start Trial   Start Trial
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997   Start Trial   Start Trial
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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