Details for New Drug Application (NDA): 019430
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NDA 019430 describes EPIPEN JR., which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from six suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EPIPEN JR. profile page.
The generic ingredient in EPIPEN JR. 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 EPIPEN JR. 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 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: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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