Details for New Drug Application (NDA): 212097
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NDA 212097 describes GVOKE PFS, which is a drug marketed by Xeris 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 GVOKE PFS profile page.
The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glucagon profile page.
The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glucagon profile page.
Suppliers and Packaging for NDA: 212097
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GVOKE VIALDX | glucagon | SOLUTION;INTRAVENOUS | 212097 | NDA | American Regent, Inc. | 0517-2901 | 0517-2901-01 | 1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL |
| GVOKE VIALDX | glucagon | SOLUTION;INTRAVENOUS | 212097 | NDA | American Regent, Inc. | 0517-2901 | 0517-2901-10 | 10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.5MG/0.1ML (0.5MG/0.1ML) | ||||
| Approval Date: | Sep 10, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 11,590,205 | Patent Expiration: | Apr 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SEVERE HYPOGLYCEMIA | ||||||||
| Patent: | 9,649,364 | Patent Expiration: | Apr 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SEVERE HYPOGLYCEMIA | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 1MG/0.2ML (1MG/0.2ML) | ||||
| Approval Date: | Sep 10, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 11,590,205 | Patent Expiration: | Apr 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SEVERE HYPOGLYCEMIA | ||||||||
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