Details for New Drug Application (NDA): 205029
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NDA 205029 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 205029
| Tradename: | EPINEPHRINE |
| Applicant: | Bpi Labs |
| Ingredient: | epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 205029
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 205029
Suppliers and Packaging for NDA: 205029
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 205029 | NDA | Henry Schein, Inc. | 0404-9857 | 0404-9857-01 | 1 AMPULE in 1 BAG (0404-9857-01) / 1 mL in 1 AMPULE |
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 205029 | NDA | A-S Medication Solutions | 50090-3039 | 50090-3039-1 | 1 mL in 1 AMPULE (50090-3039-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | Strength | 1MG/ML (1MG/ML) | ||||
| Approval Date: | Jul 29, 2014 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | Feb 4, 2022 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 12, 2023 | TE: | RLD: | Yes | |||||
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