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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Generated: December 13, 2017

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. Seventeen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for 200540

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 10544-955-14 14 TABLET, DELAYED RELEASE in 1 BOTTLE (10544-955-14)
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540 ANDA Eagle Pharmaceuticals, Inc. 42367-110 42367-110-09 90 TABLET, DELAYED RELEASE in 1 BOTTLE (42367-110-09)

Summary for product number 001

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

Summary 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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Serving leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
US Department of Justice
Express Scripts
Daiichi Sankyo

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