Details for New Drug Application (NDA): 213708
NDA 213708 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Apotex, Baxter Hlthcare Corp, Bpi Labs, Deva Hlding, Fresenius Kabi Usa, Gland, Hikma, Intl Medication Sys, Zydus Pharms, Hospira, and Teva Pharms Usa, and is included in twenty 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 213708
| Tradename: | EPINEPHRINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 213708
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 213708
Suppliers and Packaging for NDA: 213708
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE | epinephrine | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | 213708 | ANDA | Fresenius Kabi USA, LLC | 63323-696 | 63323-696-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-696-25) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-696-02) |
| EPINEPHRINE | epinephrine | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | 213708 | ANDA | REMEDYREPACK INC. | 70518-4274 | 70518-4274-0 | 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-4274-0) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-4274-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | Strength | 1MG/ML (1MG/ML) | ||||
| Approval Date: | Nov 20, 2024 | TE: | AP | RLD: | No | ||||
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