# EPI E Z PEN JR / EPIPEN / EPIPEN E Z PEN / EPIPEN JR. — FDA application NDA019430

Informational only - not investment advice.

Application NDA019430 · type NDA · FDA status: approved · original approval 1987-12-22

Listed sponsor: VIATRIS · [VTRS company profile](/company/VTRS/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | EPIPEN | EPINEPHRINE | INJECTABLE | INTRAMUSCULAR, SUBCUTANEOUS | 0.3MG/DELIVERY | Prescription | AB | Yes |
| 002 | EPIPEN JR. | EPINEPHRINE | INJECTABLE | INTRAMUSCULAR, SUBCUTANEOUS | 0.15MG/DELIVERY | Prescription | AB | Yes |
| 003 | EPIPEN E Z PEN | EPINEPHRINE | INJECTABLE | INTRAMUSCULAR | 0.3MG/DELIVERY | Discontinued | not listed | No |
| 004 | EPI E Z PEN JR | EPINEPHRINE | INJECTABLE | INTRAMUSCULAR | 0.15MG/DELIVERY | Discontinued | not listed | No |

## Orange Book patent and exclusivity listings

No Orange Book patent or exclusivity listings joined to this application.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- EPINEPHRINE · UNII YKH834O4BH · [lmmol compound UCTWMZQNUQWSLP-VIFPVBQESA-N](https://lmmol.com/compound/UCTWMZQNUQWSLP-VIFPVBQESA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/VTRS/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA019430. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.