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Details for New Drug Application (NDA): 205223

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NDA 205223 describes NUVESSA, which is a drug marketed by Allergan Sales Llc 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-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for NDA: 205223

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 205223


Suppliers and Packaging for NDA: 205223

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;VAGINAL 205223 NDA Allergan, Inc. 0023-5920 0023-5920-05 1 APPLICATOR in 1 CARTON (0023-5920-05) > 5 g in 1 APPLICATOR
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength1.3%
Approval Date:Mar 24, 2014TE:RLD:Yes
Patent:7,893,097Patent Expiration:Feb 19, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,877,792Patent Expiration:Feb 2, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Mar 24, 2017
Regulatory Exclusivity Use:NEW PRODUCT

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.