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Generated: December 18, 2017

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:1
Applicant:1
Ingredient:1
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 0179-0218-98 2 TABLET in 1 CARTON (0179-0218-98)
MISOPROSTOL misoprostol TABLET;ORAL 091667 ANDA Aidarex Pharmaceuticals LLC 33261-076 33261-076-31 3 TABLET in 1 BOTTLE, PLASTIC (33261-076-31)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Daiichi Sankyo
Novartis
Harvard Business School
Covington
US Department of Justice
Fish and Richardson
Fuji
Merck

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