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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
AstraZeneca
Dow
Moodys
Julphar
UBS
Argus Health
Covington
Teva

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200158

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NDA 200158 describes DICLOFENAC SODIUM AND MISOPROSTOL, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, and Sandoz, and is included in four NDAs. It is available from eight suppliers. Additional details are available on the DICLOFENAC SODIUM AND MISOPROSTOL profile page.

The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 200158
Tradename:DICLOFENAC SODIUM AND MISOPROSTOL
Applicant:Sandoz
Ingredient:diclofenac sodium; misoprostol
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG;0.2MG
Approval Date:May 9, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG;0.2MG
Approval Date:May 9, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Cipla
Johnson and Johnson
Deloitte
Moodys
Covington
Mallinckrodt
McKinsey

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