Details for New Drug Application (NDA): 209359
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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 209359
| Tradename: | EPINEPHRINE |
| Applicant: | Hospira |
| Ingredient: | epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 209359
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 209359
Suppliers and Packaging for NDA: 209359
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE | epinephrine | SOLUTION;INTRAVENOUS | 209359 | NDA | Hospira, Inc. | 0409-4933 | 0409-4933-10 | 10 CARTON in 1 PACKAGE (0409-4933-10) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE (0409-4933-05) |
| EPINEPHRINE | epinephrine | SOLUTION;INTRAVENOUS | 209359 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1531 | 51662-1531-1 | 1 SYRINGE, GLASS in 1 CARTON (51662-1531-1) / 10 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/10ML (0.1MG/ML) | ||||
| Approval Date: | Nov 5, 2019 | TE: | RLD: | Yes | |||||
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