Details for New Drug Application (NDA): 219239
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NDA 219239 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Baxter Hlthcare Corp, Bpi Labs, Deva Hlding, Fresenius Kabi Usa, Gland, Hikma, Intl Medication Sys, Hospira, and Teva Pharms Usa, and is included in eighteen NDAs. It is available from eighteen suppliers. There is one patent protecting this drug. Additional details are available on the EPINEPHRINE profile page.
The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.
The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.
Summary for 219239
| Tradename: | EPINEPHRINE |
| Applicant: | Gland |
| Ingredient: | epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 219239
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 219239
Suppliers and Packaging for NDA: 219239
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 219239 | ANDA | Gland Pharma Limited | 68083-633 | 68083-633-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-633-01) / 10 mL in 1 VIAL, MULTI-DOSE |
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 219239 | ANDA | Gland Pharma Limited | 68083-685 | 68083-685-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-685-01) / 30 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | Feb 6, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | 30MG/30ML (1MG/ML) | ||||
| Approval Date: | Oct 2, 2025 | TE: | AP | RLD: | No | ||||
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