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Serving leading biopharmaceutical companies globally:

Julphar
UBS
Deloitte
US Department of Justice
Harvard Business School
McKesson
Citi
Queensland Health
AstraZeneca
Dow

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205223

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NDA 205223 describes NUVESSA, which is a drug marketed by Chemo Research Sl and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the NUVESSA profile page.

The generic ingredient in NUVESSA is metronidazole. There are eighteen drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 205223
Tradename:NUVESSA
Applicant:Chemo Research Sl
Ingredient:metronidazole
Patents:5
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205223
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 205223
Suppliers and Packaging for NDA: 205223
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUVESSA metronidazole GEL;VAGINAL 205223 NDA Allergan, Inc. 0023-5920 0023-5920-05 1 APPLICATOR in 1 CARTON (0023-5920-05) > 5 g in 1 APPLICATOR
NUVESSA metronidazole GEL;VAGINAL 205223 NDA Actavis Pharma, Inc. 52544-157 52544-157-26 1 PACKAGE in 1 CARTON (52544-157-26) > 1 APPLICATOR in 1 PACKAGE > 5 g in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength1.3%
Approval Date:Mar 24, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 24, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ SubscribePatent Expiration:Feb 19, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Jun 27, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF BACTERIAL VAGINOSIS

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Serving leading biopharmaceutical companies globally:

Healthtrust
Citi
Covington
Fish and Richardson
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QuintilesIMS
Novartis
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Accenture

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