BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Argus Health
Johnson and Johnson
Farmers Insurance
Boehringer Ingelheim
US Army

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076095

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NDA 076095 describes MISOPROSTOL, which is a drug marketed by Ivax Sub Teva Pharms and Novel Labs Inc and is included in two NDAs. It is available from thirteen suppliers. Additional details are available on the MISOPROSTOL profile page.

The generic ingredient in MISOPROSTOL is misoprostol. There are fourteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
Summary for 076095
Pharmacology for NDA: 076095
Medical Subject Heading (MeSH) Categories for 076095
Suppliers and Packaging for NDA: 076095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MISOPROSTOL misoprostol TABLET;ORAL 076095 ANDA Bryant Ranch Prepack 63629-3243 63629-3243-2 60 TABLET in 1 BOTTLE (63629-3243-2)
MISOPROSTOL misoprostol TABLET;ORAL 076095 ANDA Bryant Ranch Prepack 63629-3243 63629-3243-1 30 TABLET in 1 BOTTLE (63629-3243-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jul 10, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Jul 10, 2002TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Daiichi Sankyo

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