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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 208711


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NDA 208711 describes EGATEN, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the EGATEN profile page.

The generic ingredient in EGATEN is triclabendazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the triclabendazole profile page.
Summary for 208711
Tradename:EGATEN
Applicant:Novartis
Ingredient:triclabendazole
Patents:0
Generic Entry Opportunity Date for 208711
Generic Entry Date for 208711*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER
Dosage:
TABLET;ORAL

*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.

Suppliers and Packaging for NDA: 208711
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EGATEN triclabendazole TABLET;ORAL 208711 NDA Novartis Pharmaceuticals Corporation 0078-0937 0078-0937-91 4 TABLET in 1 BLISTER PACK (0078-0937-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Feb 13, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 13, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:Feb 13, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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