Details for New Drug Application (NDA): 207568
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NDA 207568 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Bpi Labs, Intl Medication Sys, Hospira, and Teva Pharms Usa, and is included in eight NDAs. It is available from nine suppliers. There are three patents protecting this drug. Additional details are available on the EPINEPHRINE profile page.
The generic ingredient in EPINEPHRINE is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
The generic ingredient in EPINEPHRINE is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 207568
| Tradename: | EPINEPHRINE |
| Applicant: | Am Regent |
| Ingredient: | epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 207568
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 207568
Suppliers and Packaging for NDA: 207568
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 207568 | ANDA | American Regent, Inc. | 0517-1171 | 0517-1171-10 | 10 AMPULE in 1 BOX (0517-1171-10) / 1 mL in 1 AMPULE (0517-1171-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Jul 6, 2018 | TE: | RLD: | No | |||||
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