Details for New Drug Application (NDA): 209296
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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 |
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: | 10,500,208 | Patent Expiration: | Sep 18, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 10,624,850 | 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: | 10,953,018 | 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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