Details for New Drug Application (NDA): 216686
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NDA 216686 describes FOCINVEZ, which is a drug marketed by Steriscience and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the FOCINVEZ profile page.
The generic ingredient in FOCINVEZ is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
The generic ingredient in FOCINVEZ is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 216686
| Tradename: | FOCINVEZ |
| Applicant: | Steriscience |
| Ingredient: | fosaprepitant dimeglumine |
| Patents: | 2 |
Suppliers and Packaging for NDA: 216686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOCINVEZ | fosaprepitant dimeglumine | SOLUTION;INTRAVENOUS | 216686 | NDA | Amneal Pharmaceuticals LLC | 70121-2631 | 70121-2631-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2631-1) / 50 mL in 1 VIAL, SINGLE-DOSE |
| FOCINVEZ | fosaprepitant dimeglumine | SOLUTION;INTRAVENOUS | 216686 | NDA | Steriscience Specialties Private Limited | 82449-231 | 82449-231-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82449-231-01) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 150MG BASE/50ML (EQ 3MG BASE/ML) | ||||
| Approval Date: | Aug 22, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 11,065,265 | Patent Expiration: | Jan 11, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,042,504 | Patent Expiration: | Jan 11, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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