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 fourteen 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. Seven suppliers are listed for this compound. Additional details are available on the aprepitant profile page.
The generic ingredient in APONVIE is aprepitant. There are twenty-six drug master file entries for this compound. Seven 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: | 14 |
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: | ⤷ Get Started Free | Patent Expiration: | Sep 18, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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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