Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Baxter
UBS
Mallinckrodt
QuintilesIMS
Queensland Health
Dow
Farmers Insurance
Medtronic

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201089

« Back to Dashboard

NDA 201089 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 ten 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. Seventeen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 201089
Tradename:DICLOFENAC SODIUM AND MISOPROSTOL
Applicant:Actavis Labs Fl Inc
Ingredient:diclofenac sodium; misoprostol
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 201089 ANDA Actavis Pharma, Inc. 0591-0397 N 0591-0397-19
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 201089 ANDA Actavis Pharma, Inc. 0591-0397 N 0591-0397-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG;0.2MG
Approval Date:Jul 9, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG;0.2MG
Approval Date:Jul 9, 2012TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Accenture
Cerilliant
Covington
Teva
Daiichi Sankyo
Chinese Patent Office
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.