Details for New Drug Application (NDA): 019430
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The generic ingredient in EPIPEN JR. is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 019430
Tradename: | EPIPEN JR. |
Applicant: | Mylan Speciality Lp |
Ingredient: | epinephrine |
Patents: | 5 |
Pharmacology for NDA: 019430
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 019430
Suppliers and Packaging for NDA: 019430
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPI E Z PEN JR | epinephrine | INJECTABLE;INTRAMUSCULAR | 019430 | NDA AUTHORIZED GENERIC | Mylan Specialty L.P. | 49502-101 | 49502-101-02 | 2 CONTAINER in 1 CARTON (49502-101-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-101-01) / .3 mL in 1 SYRINGE, GLASS |
EPI E Z PEN JR | epinephrine | INJECTABLE;INTRAMUSCULAR | 019430 | NDA AUTHORIZED GENERIC | Mylan Specialty L.P. | 49502-102 | 49502-102-02 | 2 CONTAINER in 1 CARTON (49502-102-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-102-01) / .3 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 0.3MG/DELIVERY | ||||
Approval Date: | Dec 22, 1987 | TE: | AB | RLD: | Yes | ||||
Patent: | 7,449,012 | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 7,794,432 | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 8,048,035 | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
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