Details for New Drug Application (NDA): 090589
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NDA 090589 describes EPINEPHRINE (AUTOINJECTOR), which is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from four suppliers. Additional details are available on the EPINEPHRINE (AUTOINJECTOR) profile page.
The generic ingredient in EPINEPHRINE (AUTOINJECTOR) 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 (AUTOINJECTOR) 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 090589
| Tradename: | EPINEPHRINE (AUTOINJECTOR) |
| Applicant: | Teva Pharms Usa |
| Ingredient: | epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 090589
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 090589
Suppliers and Packaging for NDA: 090589
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE (AUTOINJECTOR) | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 090589 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5985 | 0093-5985-27 | 2 CONTAINER in 1 CARTON (0093-5985-27) / 1 SYRINGE in 1 CONTAINER (0093-5985-19) / .3 mL in 1 SYRINGE |
| EPINEPHRINE (AUTOINJECTOR) | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 090589 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5986 | 0093-5986-27 | 2 CONTAINER in 1 CARTON (0093-5986-27) / 1 SYRINGE in 1 CONTAINER (0093-5986-19) / .3 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 0.3MG/DELIVERY | ||||
| Approval Date: | Aug 16, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 0.15MG/DELIVERY | ||||
| Approval Date: | Aug 16, 2018 | TE: | AB | RLD: | No | ||||
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