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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Farmers Insurance
Daiichi Sankyo
US Army
Queensland Health

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200540

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NDA 200540 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. Sixteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 200540
Applicant:Exela Holdings
Ingredient:diclofenac sodium; misoprostol
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200540
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 200540 ANDA Blenheim Pharmacal, Inc. 10544-955 E 10544-955-14
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540 ANDA Eagle Pharmaceuticals, Inc. 42367-110 N 42367-110-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG;0.2MG
Approval Date:Mar 14, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG;0.2MG
Approval Date:Mar 14, 2014TE:ABRLD:No

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