Details for New Drug Application (NDA): 019430
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NDA 019430 describes EPIPEN JR., which is a drug marketed by Viatris 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. Thirty-two 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. Thirty-two suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 019430
| Tradename: | EPIPEN JR. |
| Applicant: | Viatris |
| 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 | Viatris Specialty LLC | 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 | Viatris Specialty LLC | 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? | ||
Expired US Patents for NDA 019430
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 7,449,012 | ⤷ Get Started Free |
| Viatris | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | 8,048,035 | ⤷ Get Started Free |
| Viatris | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | 9,586,010 | ⤷ Get Started Free |
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 8,870,827 | ⤷ Get Started Free |
| Viatris | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | 8,870,827 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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