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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 one supplier. 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. Seventy-seven suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for NDA: 205223

Allergan Sales Llc
Therapeutic Class:Antibacterials

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 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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