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Generated: November 19, 2018

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Details for New Drug Application (NDA): 209963

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NDA 209963 describes GOPRELTO, which is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GOPRELTO profile page.

The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cocaine hydrochloride profile page.
Summary for 209963
Tradename:GOPRELTO
Applicant:Genus Lifesciences
Ingredient:cocaine hydrochloride
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209963
Generic Entry Date for 209963*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;NASAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 209963
Suppliers and Packaging for NDA: 209963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963 NDA Genus Lifesciences Inc. 64950-359 64950-359-04 1 BOTTLE, GLASS in 1 CARTON (64950-359-04) > 4 mL in 1 BOTTLE, GLASS
GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963 NDA AUTHORIZED GENERIC Genus Lifesciences Inc. 64950-362 64950-362-04 1 BOTTLE, GLASS in 1 CARTON (64950-362-04) > 4 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;NASALStrength4%
Approval Date:Dec 14, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Feb 7, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT
Patent:➤ Try a Free TrialPatent Expiration:Feb 7, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN GERIATRIC PATIENTS

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