Orange Book product · Brand (NDA)
EPIPEN
EPINEPHRINE
At a glance
Dec 22, 1987
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1987
39 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
EPINEPHRINE
Strength
0.3MG/DELIVERY
Dosage form
INJECTABLE
Route
INTRAMUSCULAR, SUBCUTANEOUS
TE code
AB
Application
NDA 019430
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026EPINEPHRINEBrand (NDA)
NDA 220626 · BAXTER HLTHCARE CORP
- 2025EPINEPHRINEBrand (NDA)
NDA 215425 · FRESENIUS KABI USA
- 2025NEFFYBrand (NDA)
NDA 214697 · ARS PHARMS OPERATION
- 2024EPINEPHRINEBrand (NDA)
NDA 205029 · BPI LABS
- 2023ADRENALINBrand (NDA)
NDA 215875 · PH HEALTH
- 2022EPINEPHRINEBrand (NDA)
NDA 211363 · INTL MEDICATION SYS
- 2019EPINEPHRINEBrand (NDA)
NDA 209359 · HOSPIRA
- 2018PRIMATENE MISTBrand (NDA)
NDA 205920 · ARMSTRONG PHARMS
- 2018SYMJEPIBrand (NDA)
NDA 207534 · ADAMIS PHARMS CORP
- 2017AUVI-QBrand (NDA)
NDA 201739 · KALEO INC
- 2013ADRENALINBrand (NDA)
NDA 204640 · PH HEALTH
- 2012ADRENALINBrand (NDA)
NDA 204200 · PH HEALTH
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
