Details for New Drug Application (NDA): 216457
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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: | RX | Dosage: | EMULSION;INTRAVENOUS | Strength | 32MG/4.4ML (7.2MG/ML) | ||||
Approval Date: | Sep 16, 2022 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 18, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 18, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A METHOD OF ADMINISTERING APREPITANT FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 18, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A METHOD OF ADMINISTERING APREPITANT FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING |
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