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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 216457


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NDA 216457 describes APONVIE, which is a drug marketed by Heron Theraps Inc and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the APONVIE profile page.

The generic ingredient in APONVIE is aprepitant. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aprepitant profile page.
Summary for 216457
Tradename:APONVIE
Applicant:Heron Theraps Inc
Ingredient:aprepitant
Patents:11
Suppliers and Packaging for NDA: 216457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APONVIE aprepitant EMULSION;INTRAVENOUS 216457 NDA Heron Therapeutics, Inc. 47426-401 47426-401-10 10 VIAL, GLASS in 1 CARTON (47426-401-10) / 4.4 mL in 1 VIAL, GLASS (47426-401-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength32MG/4.4ML (7.2MG/ML)
Approval Date:Sep 16, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 18, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 18, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF ADMINISTERING APREPITANT FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
Patent:⤷  Sign UpPatent Expiration:Sep 18, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF ADMINISTERING APREPITANT FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING

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