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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076095

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NDA 076095 describes MISOPROSTOL, which is a drug marketed by Novel Labs Inc and Ivax Sub Teva Pharms and is included in two NDAs. It is available from twelve 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 NDA: 076095

Therapeutic Class:Gastrointestinal Agents
Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076095

Suppliers and Packaging for NDA: 076095

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 076095 ANDA Bryant Ranch Prepack 63629-3243 63629-3243-1 30 TABLET in 1 BOTTLE (63629-3243-1)
TABLET;ORAL 076095 ANDA Bryant Ranch Prepack 63629-3243 63629-3243-2 60 TABLET in 1 BOTTLE (63629-3243-2)

Summary for product number 001

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

Summary for product number 002

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

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