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Baxter
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Generated: April 27, 2018

DrugPatentWatch Database Preview

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 seven 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. Seventeen 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
Formulation / Manufacturing:see details
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 N 0025-1411-34
ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1411 N 0025-1411-60

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

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Chubb
UBS
Citi
Daiichi Sankyo
US Department of Justice
Covington
Cerilliant
Fuji

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