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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091667

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NDA 091667 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 091667
Tradename:MISOPROSTOL
Applicant:Novel Labs Inc
Ingredient:misoprostol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)
Formulation / Manufacturing:see details
Pharmacology for NDA: 091667
Medical Subject Heading (MeSH) Categories for 091667
Suppliers and Packaging for NDA: 091667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MISOPROSTOL misoprostol TABLET;ORAL 091667 ANDA KAISER FOUNDATION HOSPITALS 0179-0218 N 0179-0218-98
MISOPROSTOL misoprostol TABLET;ORAL 091667 ANDA Aidarex Pharmaceuticals LLC 33261-076 N 33261-076-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jul 25, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Jul 25, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
Chubb
US Department of Justice
Boehringer Ingelheim
Cipla
McKesson
Express Scripts
Mallinckrodt

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