Details for New Drug Application (NDA): 209296
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NDA 209296 describes CINVANTI, which is a drug marketed by Heron Theraps Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the CINVANTI profile page.
The generic ingredient in CINVANTI 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.
The generic ingredient in CINVANTI 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 209296
| Tradename: | CINVANTI |
| Applicant: | Heron Theraps Inc |
| Ingredient: | aprepitant |
| Patents: | 10 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209296
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CINVANTI | aprepitant | EMULSION;INTRAVENOUS | 209296 | NDA | Heron Therapeutics, Inc. | 47426-201 | 47426-201-01 | 1 VIAL, GLASS in 1 CARTON (47426-201-01) / 18 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;INTRAVENOUS | Strength | 130MG/18ML (7.2MG/ML) | ||||
| Approval Date: | Nov 9, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 18, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 18, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NAUSEA AND VOMITING, INCLUDING THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY OR MODERATELY EMETOGENIC CANCER CHEMOTHERAPY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 18, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NAUSEA AND VOMITING, INCLUDING THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY OR MODERATELY EMETOGENIC CANCER CHEMOTHERAPY | ||||||||
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