Details for New Drug Application (NDA): 212097
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The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Four 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 HYPOPEN | glucagon | SOLUTION;SUBCUTANEOUS | 212097 | NDA | Xeris Pharmaceuticals, Inc. | 72065-120 | 72065-120-11 | 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC |
GVOKE KIT | glucagon | SOLUTION;SUBCUTANEOUS | 212097 | NDA | Xeris Pharmaceuticals, Inc. | 72065-120 | 72065-120-11 | 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC |
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: | ⤷ Sign Up | Patent Expiration: | Apr 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF SEVERE HYPOGLYCEMIA | ||||||||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Apr 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF SEVERE HYPOGLYCEMIA |
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