Details for New Drug Application (NDA): 213708
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NDA 213708 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Hospira, Teva Pharms Usa, and Baxter Hlthcare Corp, and is included in fourteen NDAs. It is available from fifteen suppliers. Additional details are available on the EPINEPHRINE profile page.
The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are twenty-one 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 twenty-one 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 | ||||
| Regulatory Exclusivity Expiration: | Jun 3, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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